The following data is part of a premarket notification filed by Zoll Circulation with the FDA for Autopulse Resuscitation System Model100.
| Device ID | K063602 |
| 510k Number | K063602 |
| Device Name: | AUTOPULSE RESUSCITATION SYSTEM MODEL100 |
| Classification | Compressor, Cardiac, External |
| Applicant | ZOLL CIRCULATION 249 HUMBOLDT COURT Sunnyvale, CA 94089 |
| Contact | Mark Perkins |
| Correspondent | Mark Perkins ZOLL CIRCULATION 249 HUMBOLDT COURT Sunnyvale, CA 94089 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-04 |
| Decision Date | 2006-12-21 |
| Summary: | summary |