Autopulse Resuscitation System, Model 100
FDA 510(k) K072527 · Zoll Circulation
510(k) numberK072527
Submission
- Device name
- Autopulse Resuscitation System, Model 100
- Applicant
- Zoll Circulation
Sunnyvale, CA, US - Received
- September 7, 2007
- Decision date
- March 19, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRM – Compressor, Cardiac, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5200
- Specialty
- Cardiovascular
Other 510(k)s with product code DRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221700 | AutoPulse NXT Resuscitation SystemDRM · Traditional | Zoll Circulation, Inc. | 03/09/2023SE |
| K211289 | RMU-2000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 11/09/2021SE |
| K173553 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 02/08/2018SE |
| K161768 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 11/09/2016SE |
| K153628 | ROSC-U Mini Chest Compressor (RMCC)DRM · Traditional | Resuscitation International, LLC | 01/30/2016SE |
| K141809 | RMU-1000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 10/27/2014SE |
| K112998 | Autopulse Resuscitation System Model 1000DRM · Traditional | Zoll Circulation | 03/15/2012SE |
| K102068 | Miniaturize Chest Compressor (MCC)DRM · Traditional | Resuscitation International | 11/16/2010SE |
| K090422 | Lucas 2DRM · Traditional | Jolife AB | 06/17/2009SE |
| K073079 | Thumper, Model: 1008DRM · Traditional | Michigan Instruments, Inc. | 02/14/2008SE |
More from Michigan Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management…NZE · Traditional | 10/15/2025SE |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management SystemNZE · Traditional | 11/03/2023SE |
| K221700 | AutoPulse NXT Resuscitation SystemDRM · Traditional | 03/09/2023SE |
| K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Special | 01/13/2023SESU |
| K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | 06/02/2022SESU |
| K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | 12/20/2021SESU |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX · Traditional | 03/24/2016SESU |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…NCX · Traditional | 10/30/2015SESU |
| K141139 | Solex Intravascular Heat Exchange CatheterNCX · Traditional | 10/03/2014SE |
| K112998 | Autopulse Resuscitation System Model 1000DRM · Traditional | 03/15/2012SE |
Questions and answers
When was Autopulse Resuscitation System, Model 100 cleared by the FDA?
Autopulse Resuscitation System, Model 100 (K072527) received a 510(k) decision of Substantially Equivalent on March 19, 2008, 194 days after the submission was received.
What is the product code of K072527?
The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.