The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Pulsemate Bx-5.
| Device ID | K874692 |
| 510k Number | K874692 |
| Device Name: | PULSEMATE BX-5 |
| Classification | Oximeter |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 1330 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | Edward M Lebow |
| Correspondent | Edward M Lebow COLIN MEDICAL INSTRUMENTS CORP. 1330 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-16 |
| Decision Date | 1988-02-02 |