The following data is part of a premarket notification filed by Epic Medical Equipment Services, Inc. with the FDA for Oximeter Pre-amp Cable.
Device ID | K965172 |
510k Number | K965172 |
Device Name: | OXIMETER PRE-AMP CABLE |
Classification | Oximeter |
Applicant | EPIC MEDICAL EQUIPMENT SERVICES, INC. 4643 WESTGROVE Dallas, TX 75248 |
Contact | Jeffrey Secunda |
Correspondent | Jeffrey Secunda EPIC MEDICAL EQUIPMENT SERVICES, INC. 4643 WESTGROVE Dallas, TX 75248 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-24 |
Decision Date | 1997-07-16 |