The following data is part of a premarket notification filed by Omnicon Medical Corp. with the FDA for Conductive Anesthsia Breath. Circuit.
Device ID | K760149 |
510k Number | K760149 |
Device Name: | CONDUCTIVE ANESTHSIA BREATH. CIRCUIT |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | OMNICON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-30 |
Decision Date | 1976-07-19 |