The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Interspec Apogee.
| Device ID | K890173 |
| 510k Number | K890173 |
| Device Name: | INTERSPEC APOGEE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Contact | E Thomenius |
| Correspondent | E Thomenius INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-17 |
| Decision Date | 1989-04-14 |