The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Bp8800t/8000ir/8300g Non-invasive Blood Pres. Syst.
| Device ID | K921048 |
| 510k Number | K921048 |
| Device Name: | BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio, TX 78249 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio, TX 78249 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-04 |
| Decision Date | 1993-07-01 |