The following data is part of a premarket notification filed by Foregger Air Products & Chem., Inc. with the FDA for Ventilator Circuits.
Device ID | K760565 |
510k Number | K760565 |
Device Name: | VENTILATOR CIRCUITS |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | FOREGGER AIR PRODUCTS & CHEM., INC. 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 | 1976-09-02 |
Decision Date | 1976-09-16 |