The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Interspec Apogee Cla.
Device ID | K924231 |
510k Number | K924231 |
Device Name: | INTERSPEC APOGEE CLA |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
Contact | Arthur J Schenck |
Correspondent | Arthur J Schenck INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-21 |
Decision Date | 1993-06-14 |