The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Autoecho.
Device ID | K822903 |
510k Number | K822903 |
Device Name: | AUTOECHO |
Classification | Computer, Diagnostic, Pre-programmed, Single-function |
Applicant | OXFORD MEDILOG, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DXG |
CFR Regulation Number | 870.1435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-28 |
Decision Date | 1982-11-01 |