The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Flowmeter, Backpressure Compensated, Thorpe Tube.
Device ID | K850560 |
510k Number | K850560 |
Device Name: | FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE |
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 | 1985-02-12 |
Decision Date | 1985-04-17 |