The following data is part of a premarket notification filed by Peripheral Systems Group with the FDA for Psg(tm) 20 Guage Doppler Needle.
| Device ID | K913941 |
| 510k Number | K913941 |
| Device Name: | PSG(TM) 20 GUAGE DOPPLER NEEDLE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Jessica Ayres |
| Correspondent | Jessica Ayres PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-04 |
| Decision Date | 1992-02-27 |