510(k) K854067

SELECT FLOWMETER by Precision Medical, Inc. — Product Code CAX

K854067 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "SELECT FLOWMETER". The FDA issued a decision of Substantially Equivalent on October 29, 1985. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. Precision Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1985
Date Received
October 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Device Class
Class I
Regulation Number
868.2340
Review Panel
AN
Submission Type