The following data is part of a premarket notification filed by Zoll Circulation with the FDA for Autopulse Resuscitation System Model 1000.
Device ID | K112998 |
510k Number | K112998 |
Device Name: | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 |
Classification | Compressor, Cardiac, External |
Applicant | ZOLL CIRCULATION 2000 Ringwood Ave San Jose, CA 95131 |
Contact | Sam Nanavati |
Correspondent | Sam Nanavati ZOLL CIRCULATION 2000 Ringwood Ave San Jose, CA 95131 |
Product Code | DRM |
CFR Regulation Number | 870.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-07 |
Decision Date | 2012-03-15 |
Summary: | summary |