The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Angioscope.
Device ID | K830084 |
510k Number | K830084 |
Device Name: | ANGIOSCOPE |
Classification | Angioscope |
Applicant | TRIMEDYNE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LYK |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-11 |
Decision Date | 1983-06-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ANGIOSCOPE 73424457 not registered Dead/Abandoned |
TRIMEDYNE, INC. 1983-05-04 |