The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Osm-1 Oxygen Saturation Monitor.
| Device ID | K853331 |
| 510k Number | K853331 |
| Device Name: | OSM-1 OXYGEN SATURATION MONITOR |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | CRITICARE SYSTEMS, INC. P.O. BOX 26556 Milwaukee, WI 53226 |
| Contact | Der Ruhr |
| Correspondent | Der Ruhr CRITICARE SYSTEMS, INC. P.O. BOX 26556 Milwaukee, WI 53226 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-08 |
| Decision Date | 1986-01-14 |