510(k) K791648

MODEL 54 FLOWMETER BACK-PRESSURE TUBE by Harris Calorific — Product Code CAX

K791648 is an FDA 510(k) premarket notification submitted by Harris Calorific for the device "MODEL 54 FLOWMETER BACK-PRESSURE TUBE". The FDA issued a decision of Substantially Equivalent on September 17, 1979. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. Harris Calorific has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1979
Date Received
August 24, 1979
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