The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Select Flowmeter.
| Device ID | K854067 |
| 510k Number | K854067 |
| Device Name: | SELECT FLOWMETER |
| Classification | Flowmeter, Tube, Thorpe, Back-pressure Compensated |
| Applicant | PRECISION MEDICAL, INC. 7285 PARK DR. Bath, PA 18014 |
| Contact | Clyde W Shuman |
| Correspondent | Clyde W Shuman PRECISION MEDICAL, INC. 7285 PARK DR. Bath, PA 18014 |
| Product Code | CAX |
| CFR Regulation Number | 868.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-04 |
| Decision Date | 1985-10-29 |