Oxygen Powered Resuscitator for CPR
FDA 510(k) K920910 · J. H. Emerson Co.
510(k) numberK920910
Submission
- Device name
- Oxygen Powered Resuscitator for CPR
- Applicant
- J. H. Emerson Co.
Cambridge, MA, US - Received
- February 27, 1992
- Decision date
- January 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5925
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional | Draegerwerk AG & CO Kgaa | 04/04/2025SE |
| K221634 | Oxymag - Transport and Emergency VentilatorBTL · Traditional | Magnamed Tecnologia Medica S/A | 05/24/2023SE |
| K202219 | VORTRAN GO2VENT with PEEP ValveBTL · Traditional | Vortran Medical Technology 1, Inc. | 02/11/2021SE |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional | Weinmann Emergency Medical Technology GmbH + Co.… | 11/20/2020SE |
| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | International Biomedical | 01/18/2019SE |
| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | Ventlab, LLC | 11/16/2018SE |
| K161420 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 06/06/2017SE |
| K162968 | Vortran GO2VENTBTL · Traditional | Vortran Medical Technology 1, Inc. | 04/10/2017SE |
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | O-Two Medical Technologies, Inc. | 03/16/2015SE |
| K142096 | T-Piece ResuscitatorBTL · Traditional | Mercury Medical | 10/17/2014SE |
More from Mercury Medical
| 510(k) | Device | Decision |
|---|---|---|
| K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingNHJ · Special | 11/22/2000SE |
| K924174 | Emerson In-Exsufflator, Models 2-CM & 2-CANHJ · Traditional | 11/17/1992SE |
| K902764 | Emerson 33-AN Negative Pressure Respirator AlarmBYT · Traditional | 11/19/1990SE |
| K896721 | Model 7-AT Treatment ChamberLGM · Traditional | 01/22/1990SE |
| K881808 | Emerson Chest Respirator, Model 33-CREBYT · Traditional | 08/04/1988SE |
| K873489 | Emerson Dispos Thoracic Drainage Set - 551-8000GCX · Traditional | 12/29/1987SE |
| K872937 | 97-TD Emerson Timer/Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K872936 | 97-D Emerson Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K864379 | Emerson 3MV Volume VentilatorCBK · Traditional | 12/15/1986SE |
| K864394 | Emerson 3MV Volume Ventilator · Traditional | 12/05/1986SE |
Questions and answers
When was Oxygen Powered Resuscitator for CPR cleared by the FDA?
Oxygen Powered Resuscitator for CPR (K920910) received a 510(k) decision of Substantially Equivalent on January 12, 1993, 320 days after the submission was received.
What is the product code of K920910?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.