The following data is part of a premarket notification filed by Avatron, Inc. with the FDA for Anesthesia Breathing Circuit.
Device ID | K851193 |
510k Number | K851193 |
Device Name: | ANESTHESIA BREATHING CIRCUIT |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | AVATRON, INC. 2970 BAY VISTA COURT P.O. BOX 429 Benicia, CA 94510 |
Contact | Russell Clark |
Correspondent | Russell Clark AVATRON, INC. 2970 BAY VISTA COURT P.O. BOX 429 Benicia, CA 94510 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-26 |
Decision Date | 1985-06-14 |