The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Monaghan Rvm, Model 760 Or Model 761.
| Device ID | K853047 |
| 510k Number | K853047 |
| Device Name: | MONAGHAN RVM, MODEL 760 OR MODEL 761 |
| Classification | Monitor, Breathing Frequency |
| 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 | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-19 |
| Decision Date | 1985-11-18 |