The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Monaghan Rvm, Model 761.
Device ID | K884942 |
510k Number | K884942 |
Device Name: | MONAGHAN RVM, MODEL 761 |
Classification | Spirometer, Monitoring (w/wo Alarm) |
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 | BZK |
CFR Regulation Number | 868.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-25 |
Decision Date | 1989-06-07 |