FDA 510(k) Applications Submitted by WELCH ALLYN, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040490 |
02/26/2004 |
WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE |
WELCH ALLYN, INC. |
| K070964 |
04/05/2007 |
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM |
WELCH ALLYN, INC. |
| K052784 |
10/03/2005 |
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 |
WELCH ALLYN, INC. |
| K053381 |
12/05/2005 |
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE |
WELCH ALLYN, INC. |
| K052158 |
08/09/2005 |
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE |
WELCH ALLYN, INC. |
| K050074 |
01/12/2005 |
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 |
WELCH ALLYN, INC. |
| K971750 |
05/12/1997 |
WELCH ALLYN PHACO ILLUMINATOR |
WELCH ALLYN, INC. |
| K003376 |
10/30/2000 |
WELCH ALLYN 11800 OPTHALMOSCOPE |
WELCH ALLYN, INC. |
| K984215 |
11/24/1998 |
WELCH ALLYN FRONT-LINE DOC |
WELCH ALLYN, INC. |
| K024005 |
12/04/2002 |
WELCH ALLYN VITAL SIGN MONITOR WITH MP506 |
WELCH ALLYN, INC. |
| K040479 |
02/25/2004 |
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 |
WELCH ALLYN, INC. |
| K001265 |
04/19/2000 |
WELCH ALLYN INSTRUMENT INTERFACE MODULE |
WELCH ALLYN, INC. |
| K031548 |
05/16/2003 |
LED HEADLIGHT |
WELCH ALLYN, INC. |
| K031549 |
05/16/2003 |
SOLID STATE LAMP [LED] HEADLIGHT |
WELCH ALLYN, INC. |
| K021756 |
05/29/2002 |
WELCH ALLYN ABPM 6100 |
WELCH ALLYN, INC. |
| K022163 |
07/03/2002 |
WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 |
WELCH ALLYN, INC. |
| K023495 |
10/18/2002 |
WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK) |
WELCH ALLYN, INC. |
| K033870 |
12/12/2003 |
IMAGE MANAGEMENT SYSTEM |
WELCH ALLYN, INC. |
| K012455 |
08/01/2001 |
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM |
WELCH ALLYN, INC. |
| K010186 |
01/22/2001 |
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM |
WELCH ALLYN, INC. |
| K030580 |
02/24/2003 |
SURETEMP PLUS |
WELCH ALLYN, INC. |
| K110516 |
02/23/2011 |
CONNEX VITAL SIGNS MONITOR 6000 SERIES |
WELCH ALLYN, INC. |
| K101680 |
06/15/2010 |
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES |
WELCH ALLYN, INC. |
| K093907 |
12/22/2009 |
WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE |
WELCH ALLYN, INC. |
| K101445 |
05/24/2010 |
VITAL SIGNS MONITOR-VSM 6000 SERIES |
WELCH ALLYN, INC. |
| K223381 |
11/07/2022 |
iExaminer System with Panoptic Plus |
Welch Allyn, Inc. |
| K070060 |
01/05/2007 |
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) |
WELCH ALLYN, INC. |
| K082478 |
08/28/2008 |
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 |
WELCH ALLYN, INC. |
| K072449 |
08/31/2007 |
CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS |
WELCH ALLYN, INC. |
| K071218 |
05/02/2007 |
PROXENON 350, MODEL 902XX |
WELCH ALLYN, INC. |
| K052160 |
08/09/2005 |
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) |
WELCH ALLYN, INC. |
| K053027 |
10/27/2005 |
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) |
WELCH ALLYN, INC. |
| K002530 |
08/16/2000 |
WELCH ALLYN SPOT CHECK DEVICE |
WELCH ALLYN, INC. |
| K980281 |
01/26/1998 |
WELCH ALLYN XENON 300 LIGHT SOURCE |
WELCH ALLYN, INC. |
| K981937 |
06/02/1998 |
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM |
WELCH ALLYN, INC. |
| K120343 |
02/03/2012 |
CONNEX WORKSTATION |
WELCH ALLYN, INC. |
| K120743 |
03/12/2012 |
SPECULUM, VAGINAL, NONMETAL |
WELCH ALLYN, INC. |
| K120774 |
03/14/2012 |
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT |
WELCH ALLYN, INC. |
| K121013 |
04/03/2012 |
CONNEX VITAL SIGNS MONITOR 6000 SERIES |
WELCH ALLYN, INC. |
| K121405 |
05/10/2012 |
PANOPTIC |
WELCH ALLYN, INC. |
| K131573 |
05/30/2013 |
CP150 ELECTROCARDIOGRAPH |
WELCH ALLYN, INC. |
| K122058 |
07/13/2012 |
FLEXIPORT ECOCUFF |
WELCH ALLYN, INC. |
| K142356 |
08/25/2014 |
Connex Spot Monitor,901058 Vital Signs Monitor Core |
WELCH ALLYN, INC. |
| K132807 |
09/09/2013 |
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) |
WELCH ALLYN, INC. |
| K132808 |
09/11/2013 |
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR |
WELCH ALLYN, INC. |
| K112687 |
09/15/2011 |
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES |
WELCH ALLYN, INC. |
| K970382 |
02/03/1997 |
VS-100 VIDEO SIGMOIDOSCOPE |
WELCH ALLYN, INC. |
| K971734 |
05/12/1997 |
VG 200 VIDEO GASTROSCOPE |
WELCH ALLYN, INC. |
| K954704 |
10/12/1995 |
VS-200 VIDEO SIGMOIDOSCOPE |
WELCH ALLYN, INC. |
| K955635 |
12/11/1995 |
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND |
WELCH ALLYN, INC. |
| K171621 |
06/02/2017 |
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor |
Welch Allyn, Inc. |
| K181016 |
04/17/2018 |
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System |
Welch Allyn, Inc. |
| K191013 |
04/17/2019 |
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option |
Welch Allyn, Inc. |
| K212473 |
08/06/2021 |
Welch Allyn Connex Central Station |
Welch Allyn, Inc. |
| K022084 |
06/27/2002 |
ATLAS MONITOR, MODELS 200,210,220 |
WELCH ALLYN, INC. |
| K001543 |
05/17/2000 |
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 |
WELCH ALLYN, INC. |
| K984033 |
11/12/1998 |
ATLAS MONITOR |
WELCH ALLYN, INC. |
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