510(k) K931473
- Device
- IMPACT MODEL 753
- Applicant
- IMPACT INSTRUMENTATION, INC.
- 510(k) number
- K931473
- Product code
- BTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-12-30
- Date received
- 1993-03-24
- Regulation
- 868.5925
- Classification name
- Ventilator, Emergency, Powered (resuscitator)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LESLIE SHERMAN
- Address
- P.O. Box 508 West Caldwell NJ US 07006 07006
FDA Registration Numbers#
- 3017365972
- 3001104093
- 2518436
- 9611500
- 2022648
- 9616567
- 3007734888
- 3030733800
- 3005803793
- 9610861
- 8043316
- 3008342612
- 3006783791
- 3011237704
- 3014220748
- 3024290085
- 3031754300
- 3005998497
- 8044169
- 3005652389
- 3025434453
- 1024404
- 2134752
- 3009884346
- 3012104670
- 9681209
- 2085602
- 1625392
- 3015997711
- 3020476987
- 3012542015
- 3008729547
- 9611451
- 3009746061
- 3012307300
- 1823393
- 3005783425
- 3013557562
- 3020460367
- 1924066
- 3003697063
- 3008258694
- 1314417
- 3036470679
- 2951529
- 1526863
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BTL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | Draegerwerk AG & CO Kgaa | 2025-04-04 |
| K221634 | Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/A | 2023-05-24 |
| K202219 | VORTRAN GO2VENT with PEEP Valve | Vortran Medical Technology 1, Inc. | 2021-02-11 |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | Weinmann Emergency Medical Technology GmbH + Co. KG | 2020-11-20 |
| K182956 | Puffin Lite Infant Resuscitation System | International Biomedical | 2019-01-18 |
| K173373 | SafeT T-Piece Resuscitator | Ventlab, LLC | 2018-11-16 |
| K161420 | MOVES SLC | Thornhill Research, Inc. | 2017-06-06 |
| K162968 | VORTRAN GO2VENT | Vortran Medical Technology 1, Inc. | 2017-04-10 |
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | O-Two Medical Technologies, Inc. | 2015-03-16 |
| K142096 | T-PIECE RESUSCITATOR | Mercury Medical | 2014-10-17 |
| K140049 | MOVES SLC | Thornhill Research, Inc. | 2014-05-29 |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | International Biomedical | 2014-05-28 |
| K131098 | EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | 2014-04-09 |
| K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | 2014-04-02 |
| K132759 | VENTRAIN | Dolphys Medical B.V. | 2014-03-26 |
Legacy Summary#
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FDA Review#
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