The following data is part of a premarket notification filed by Perimed Ab with the FDA for Pericam Psi.
| Device ID | K120884 |
| 510k Number | K120884 |
| Device Name: | PERICAM PSI |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | PERIMED AB DATAVAGEN 9 A Jarfalla, SE 17543 |
| Contact | Maria Liljevret |
| Correspondent | Maria Liljevret PERIMED AB DATAVAGEN 9 A Jarfalla, SE 17543 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-23 |
| Decision Date | 2012-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332834000165 | K120884 | 000 |
| 07332834000158 | K120884 | 000 |