The following data is part of a premarket notification filed by Osypka Medical, Inc. with the FDA for Psa Series.
| Device ID | K123916 |
| 510k Number | K123916 |
| Device Name: | PSA SERIES |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | OSYPKA MEDICAL, INC. 7855 IVANHOE AVE., SUITE 226 La Jolla, CA 92037 |
| Contact | Markus Osypka |
| Correspondent | Markus Osypka OSYPKA MEDICAL, INC. 7855 IVANHOE AVE., SUITE 226 La Jolla, CA 92037 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-19 |
| Decision Date | 2013-04-09 |
| Summary: | summary |