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 |