The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Model Ox-1 Oxygen Saturation Module.
| Device ID | K884822 |
| 510k Number | K884822 |
| Device Name: | MODEL OX-1 OXYGEN SATURATION MODULE |
| Classification | Oximeter |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 107G CORPORATE BLVD. South Plainfield, NJ 07080 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz COLIN MEDICAL INSTRUMENTS CORP. 107G CORPORATE BLVD. South Plainfield, NJ 07080 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-18 |
| Decision Date | 1989-03-02 |