The following data is part of a premarket notification filed by Catalyst Research Corp. with the FDA for Miniox V Pulse Oximeter.
| Device ID | K905310 |
| 510k Number | K905310 |
| Device Name: | MINIOX V PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | CATALYST RESEARCH CORP. 3706 CRONDALL LN. Owings Mills, MD 21117 |
| Contact | Devan Wolf |
| Correspondent | Devan Wolf CATALYST RESEARCH CORP. 3706 CRONDALL LN. Owings Mills, MD 21117 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-28 |
| Decision Date | 1991-05-28 |