The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Colin Stbp-780 Stress Test Blood Pressure Monitor.
| Device ID | K864654 |
| 510k Number | K864654 |
| Device Name: | COLIN STBP-780 STRESS TEST BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-28 |
| Decision Date | 1987-02-10 |