The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Mascot Stethoscope Probe.
Device ID | K874726 |
510k Number | K874726 |
Device Name: | MASCOT STETHOSCOPE PROBE |
Classification | Stethoscope, Electronic |
Applicant | IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
Contact | Ed Bistrick |
Correspondent | Ed Bistrick IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-18 |
Decision Date | 1988-03-31 |