The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Pilot Model 9200 Blood Pressure Measurement System.
| Device ID | K922668 |
| 510k Number | K922668 |
| Device Name: | PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio, TX 78249 |
| Contact | Susan D Golstein-fa |
| Correspondent | Susan D Golstein-fa COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio, TX 78249 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-04 |
| Decision Date | 1997-01-29 |