The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Circuit, Intensive Care Ventilator.
Device ID | K760352 |
510k Number | K760352 |
Device Name: | CIRCUIT, INTENSIVE CARE VENTILATOR |
Classification | Anesthesia Conduction Kit |
Applicant | MONAGHAN MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-02 |
Decision Date | 1976-08-11 |