510(k) K032852
- Device
- MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
- Applicant
- REVIVANT CORP.
- 510(k) number
- K032852
- Product code
- DRM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-12
- Date received
- 2003-09-12
- Regulation
- 870.5200
- Classification name
- Compressor, Cardiac, External
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BOB H KATZ
- Address
- 775 Palomar Ave. Sunnyvale CA US 94085 94085
FDA Registration Numbers#
- 3007275459
- 3010703925
- 3026976873
- 1821850
- 3010030355
- 3029871637
- 3013964848
- 3005445717
- 3015876
- 3003521780
- 3012972516
- 3008727520
- 3010617000
Source Documents#
Other 510(k) Records For Product Code DRM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221700 | AutoPulse NXT Resuscitation System | Zoll Circulation, Inc. | 2023-03-09 |
| K211289 | RMU-2000 Automated Chest Compression System | Defibtech, LLC | 2021-11-09 |
| K173553 | LUCAS 3 Chest Compression System | Jolife AB | 2018-02-08 |
| K161768 | LUCAS 3 Chest Compression System | Jolife AB | 2016-11-09 |
| K153628 | ROSC-U Mini Chest Compressor (RMCC) | Resuscitation International, LLC | 2016-01-30 |
| K141809 | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM | Defibtech, LLC | 2014-10-27 |
| K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 | Zoll Circulation | 2012-03-15 |
| K102068 | MINIATURIZE CHEST COMPRESSOR (MCC) | Resuscitation International | 2010-11-16 |
| K090422 | LUCAS 2 | Jolife AB | 2009-06-17 |
| K072527 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 | Zoll Circulation | 2008-03-19 |
| K073079 | THUMPER, MODEL: 1008 | Michigan Instruments, Inc. | 2008-02-14 |
| K063602 | AUTOPULSE RESUSCITATION SYSTEM MODEL100 | Zoll Circulation | 2006-12-21 |
| K062401 | MODIFICATION TO LUCAS | Jolife AB | 2006-09-28 |
| K062119 | HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 | Medical Products Mfg., LLC | 2006-09-22 |
| K053403 | LUCAS | Jolife AB | 2006-02-01 |
Legacy Summary#
summary
FDA Review#
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