The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Circuit, Breathing (w/ Connector, Adapt,.
Device ID | K792047 |
510k Number | K792047 |
Device Name: | CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT, |
Classification | Set, Tubing And Support, Ventilator (w Harness) |
Applicant | AIRLIFE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BZO |
CFR Regulation Number | 868.5975 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-12 |
Decision Date | 1979-10-30 |