The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Cbm-3000/cbm-2000/cbm-7000 Blood Pressure System.
Device ID | K900247 |
510k Number | K900247 |
Device Name: | CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM |
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 | 1990-01-17 |
Decision Date | 1990-07-17 |