FDA 510(k) Applications Submitted by AMBU, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010583 |
02/27/2001 |
AMBU GEL, HYDROGEL BURN DRESSING |
AMBU, INC. |
| K040991 |
04/16/2004 |
AMBU DISPOSABLE PRESSURE MANOMETER |
AMBU, INC. |
| K041026 |
04/21/2004 |
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S |
AMBU, INC. |
| K051529 |
06/09/2005 |
AMBU NEUROLINE GROUND |
AMBU, INC. |
| K041734 |
06/25/2004 |
AMBU DISPOSABLE ECG ELECTRODE |
AMBU, INC. |
| K032278 |
07/24/2003 |
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE |
AMBU, INC. |
| K982722 |
08/05/1998 |
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD |
AMBU, INC. |
| K032421 |
08/05/2003 |
AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE |
AMBU, INC. |
| K992902 |
08/30/1999 |
AMBU HAND POWER SUCTION PUMP |
AMBU, INC. |
| K042682 |
09/29/2004 |
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR |
AMBU, INC. |
| K993278 |
09/30/1999 |
AMBU NEONATE SILICONE RESUSCITATOR |
AMBU, INC. |
| K042843 |
10/14/2004 |
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS |
AMBU, INC. |
| K981891 |
05/29/1998 |
AMBU TUBECHECK |
AMBU, INC. |
| K964584 |
11/15/1996 |
AMBU SPUR NEONATE |
AMBU, INC. |
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