The following data is part of a premarket notification filed by Peerbridge Health Inc. with the FDA for Peerbridge Cor(tm) System.
| Device ID | K171936 |
| 510k Number | K171936 |
| Device Name: | Peerbridge Cor(TM) System |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Peerbridge Health INc. 1440 Broadway, 23rd Floor New York, NY 10018 |
| Contact | Arthur A. Bertolero |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-06-28 |
| Decision Date | 2017-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B608CORXT1 | K171936 | 000 |
| B608COREVENT0 | K171936 | 000 |