The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for Pocketcpr.
Device ID | K071321 |
510k Number | K071321 |
Device Name: | POCKETCPR |
Classification | Aid, Cardiopulmonary Resuscitation |
Applicant | BIO-DETEK, INC. 525 NARRAGANSETT PARK DR. Pawtucket, RI 02861 -4323 |
Contact | Mark Totman |
Correspondent | Mark Totman BIO-DETEK, INC. 525 NARRAGANSETT PARK DR. Pawtucket, RI 02861 -4323 |
Product Code | LIX |
CFR Regulation Number | 870.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-10 |
Decision Date | 2007-09-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POCKETCPR 77011381 3403749 Live/Registered |
ZOLL Medical Corporation 2006-10-01 |