The following data is part of a premarket notification filed by Zoll Circulation with the FDA for Autopulse Resuscitation System, Model 100.
Device ID | K072527 |
510k Number | K072527 |
Device Name: | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-07 |
Decision Date | 2008-03-19 |