The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Compustress Stress Testing Sys.
Device ID | K842339 |
510k Number | K842339 |
Device Name: | COMPUSTRESS STRESS TESTING SYS |
Classification | Computer, Diagnostic, Programmable |
Applicant | INTL. MEDICAL, INC. 64 INVERNESS DR EAST Englewood, CO 80110 |
Contact | James B Frederick |
Correspondent | James B Frederick INTL. MEDICAL, INC. 64 INVERNESS DR EAST Englewood, CO 80110 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-13 |
Decision Date | 1984-12-19 |