The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Modified 225/simv Volume Ventilator.
Device ID | K884389 |
510k Number | K884389 |
Device Name: | MODIFIED 225/SIMV VOLUME VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
Applicant | MONAGHAN MEDICAL CORP. FRANKLYN BLDG RT. 9 NORTH P.O. BOX 978 Plattsburgh, NY 12901 |
Contact | James A Cochie |
Correspondent | James A Cochie MONAGHAN MEDICAL CORP. FRANKLYN BLDG RT. 9 NORTH P.O. BOX 978 Plattsburgh, NY 12901 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-18 |
Decision Date | 1990-03-12 |