The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Savi Wireless, Model Pm500.
| Device ID | K091696 |
| 510k Number | K091696 |
| Device Name: | SAVI WIRELESS, MODEL PM500 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | MEDICOMP, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan Goldstein-falk |
| Correspondent | Susan Goldstein-falk MEDICOMP, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-10 |
| Decision Date | 2009-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862887000371 | K091696 | 000 |
| 00862887000357 | K091696 | 000 |