The following data is part of a premarket notification filed by Airco/ohio Medical Products with the FDA for Dabc Nonconductive Pediat. Anesth. Cir.
Device ID | K811413 |
510k Number | K811413 |
Device Name: | DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | AIRCO/OHIO MEDICAL PRODUCTS 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 | 1981-05-19 |
Decision Date | 1981-06-02 |