The following data is part of a premarket notification filed by Peripheral Systems Group with the FDA for Doppler Needle And Flow Monitor.
| Device ID | K903625 |
| 510k Number | K903625 |
| Device Name: | DOPPLER NEEDLE AND FLOW MONITOR |
| Classification | Flowmeter, Blood, Cardiovascular |
| 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 | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-10 |
| Decision Date | 1990-11-07 |