The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Intravascular Catheter W/doppler Transducer.
| Device ID | K860121 |
| 510k Number | K860121 |
| Device Name: | INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
| Contact | Allen J Tower |
| Correspondent | Allen J Tower NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-13 |
| Decision Date | 1986-06-02 |