510(k) K834260
K834260 is an FDA 510(k) premarket notification submitted by Precision Metering, Inc. for the device "RECON-2 FLOW CONTROLLER". The FDA issued a decision of Substantially Equivalent on January 10, 1984. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. Precision Metering, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1984
- Date Received
- December 7, 1983
- 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