The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Press-mate Bx-10 Vital Sign Monitor.
| Device ID | K032857 |
| 510k Number | K032857 |
| Device Name: | PRESS-MATE BX-10 VITAL SIGN MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio, TX 78249 |
| Contact | Mark Rison |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-12 |
| Decision Date | 2004-02-04 |
| Summary: | summary |