The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Interspec Apogee.
| Device ID | K903839 |
| 510k Number | K903839 |
| Device Name: | INTERSPEC APOGEE |
| Classification | Echocardiograph |
| Applicant | INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
| Contact | Kai E Thomenius |
| Correspondent | Kai E Thomenius INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-21 |
| Decision Date | 1990-11-16 |