FDA 510(k) Applications Submitted by AMY PIEPER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160238 |
02/01/2016 |
Airborne Phototherapy Light |
INTERNATIONAL BIOMEDICAL |
| K220742 |
03/14/2022 |
NxtGen Infant Transport Incubator |
International Biomedical |
| K140707 |
03/20/2014 |
LIFEBORNE INFANT RESUSCITATOR |
INTERNATIONAL BIOMEDICAL |
| K221154 |
04/21/2022 |
Infant Heel WarmerTM; Heel Snuggler« |
International Biomedical |
| K081399 |
05/19/2008 |
AVIATOR TRANSPORT INCUBATOR |
INTERNATIONAL BIOMEDICAL, LTD. |
| K221653 |
06/07/2022 |
InfaTherm Disposable Infant Warming Mattress |
International Biomedical |
| K093260 |
10/19/2009 |
AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM |
INTERNATIONAL BIOMEDICAL, LTD. |
| K182956 |
10/24/2018 |
Puffin Lite Infant Resuscitation System |
International Biomedical |
| K173516 |
11/14/2017 |
NuBorne Infant Warmer |
International Biomedical |
| K103523 |
12/01/2010 |
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
| K103524 |
12/01/2010 |
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
| K103525 |
12/01/2010 |
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
| K103527 |
12/01/2010 |
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
| K193481 |
12/17/2019 |
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System |
International Biomedical |
| K022873 |
08/29/2002 |
POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) |
INTERNATIONAL BIOMEDICAL, INC. |
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