The following data is part of a premarket notification filed by Catalyst Research Corp. with the FDA for Miniox Iv Portable Pulse Oximeter.
Device ID | K874132 |
510k Number | K874132 |
Device Name: | MINIOX IV PORTABLE 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 | 1987-10-13 |
Decision Date | 1988-01-19 |