The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Press-mate Bp8800ms Automatic Non-invasive Blood Pressure System.
| Device ID | K942871 |
| 510k Number | K942871 |
| Device Name: | PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk COLIN MEDICAL INSTRUMENTS CORP. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-17 |
| Decision Date | 1994-10-17 |