The following data is part of a premarket notification filed by Gmp/companies, Inc. with the FDA for Lifesyne Systems.
| Device ID | K030795 |
| 510k Number | K030795 |
| Device Name: | LIFESYNE SYSTEMS |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | GMP/COMPANIES, INC. ONE EAST BROWARD BLVD. SUITE 1701 Fort Lauderdale, FL 33301 |
| Contact | Ralph Jugo |
| Correspondent | Ralph Jugo GMP/COMPANIES, INC. ONE EAST BROWARD BLVD. SUITE 1701 Fort Lauderdale, FL 33301 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-12 |
| Decision Date | 2003-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849593016339 | K030795 | 000 |
| 20849593005344 | K030795 | 000 |
| 00849593005784 | K030795 | 000 |
| 20849593005801 | K030795 | 000 |
| 00849593005395 | K030795 | 000 |
| 00849593005388 | K030795 | 000 |
| 00849593005791 | K030795 | 000 |
| 00849593005814 | K030795 | 000 |
| 00849593005821 | K030795 | 000 |
| 00849593007641 | K030795 | 000 |
| 00849593007658 | K030795 | 000 |
| 00849593008228 | K030795 | 000 |
| 00849593025478 | K030795 | 000 |