The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Sm-20 Cardioscan Doppler Option With Cfm700 Probes.
| Device ID | K863372 |
| 510k Number | K863372 |
| Device Name: | SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Contact | Mark E Schafer |
| Correspondent | Mark E Schafer INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-02 |
| Decision Date | 1986-11-04 |