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 |