The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Cardioscan Doppler Option.
| Device ID | K860579 |
| 510k Number | K860579 |
| Device Name: | CARDIOSCAN DOPPLER OPTION |
| Classification | Transducer, Ultrasonic |
| Applicant | INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Contact | Richard B Bernardi |
| Correspondent | Richard B Bernardi INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-18 |
| Decision Date | 1986-06-30 |