AMBU MATIC AUTOMATIC RESUSCITATOR
FDA 510(k) clearance K904920 · decided 1991-05-28
Clearance details
- K-number
- K904920
- Device name
- AMBU MATIC AUTOMATIC RESUSCITATOR
- Applicant
- Ambu, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-31
- Decision date
- 1991-05-28
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- BTL
- Device class
- 2
- Regulation number
- 868.5925
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Hanover, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (K242769) | Draegerwerk AG & CO Kgaa | 2025-04-04 |
| Oxymag - Transport and Emergency Ventilator (K221634) | Magnamed Tecnologia Medica S/A | 2023-05-24 |
| VORTRAN GO2VENT with PEEP Valve (K202219) | Vortran Medical Technology 1, Inc. | 2021-02-11 |
| MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (K193191) | Weinmann Emergency Medical Technology GmbH + Co. KG | 2020-11-20 |
| Puffin Lite Infant Resuscitation System (K182956) | International Biomedical | 2019-01-18 |
| SafeT T-Piece Resuscitator (K173373) | Ventlab, LLC | 2018-11-16 |
| MOVES SLC (K161420) | Thornhill Research, Inc. | 2017-06-06 |
| VORTRAN GO2VENT (K162968) | Vortran Medical Technology 1, Inc. | 2017-04-10 |
| O-TWO E700,O-TWO E600,O-TWO E500 (K141595) | O-Two Medical Technologies, Inc. | 2015-03-16 |
| T-PIECE RESUSCITATOR (K142096) | Mercury Medical | 2014-10-17 |
| MOVES SLC (K140049) | Thornhill Research, Inc. | 2014-05-29 |
| LIFEBORNE INFANT RESUSCITATOR (K140707) | International Biomedical | 2014-05-28 |
Recalls involving this device
No recalls on record reference this clearance.