The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Cardioscan With Doppler Option.
| Device ID | K862913 |
| 510k Number | K862913 |
| Device Name: | CARDIOSCAN WITH DOPPLER OPTION |
| Classification | Transducer, Ultrasonic |
| Applicant | INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Contact | Schafer, M.sc. |
| Correspondent | Schafer, M.sc. 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 | 1986-08-01 |
| Decision Date | 1986-11-04 |