The following data is part of a premarket notification filed by Gabel Medical Instruments, Ltd. with the FDA for Qa Pressure Measurement System.
| Device ID | K925052 |
| 510k Number | K925052 |
| Device Name: | QA PRESSURE MEASUREMENT SYSTEM |
| Classification | System, Pressure Measurement, Intermittent |
| Applicant | GABEL MEDICAL INSTRUMENTS, LTD. 4243 GLANFORD AVENUE Victoria, Prov. B.c., CA V8z 4b9 |
| Contact | Lara Farris |
| Correspondent | Lara Farris GABEL MEDICAL INSTRUMENTS, LTD. 4243 GLANFORD AVENUE Victoria, Prov. B.c., CA V8z 4b9 |
| Product Code | JFC |
| CFR Regulation Number | 890.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-06 |
| Decision Date | 1993-03-09 |