510(k) K812419
K812419 is an FDA 510(k) premarket notification submitted by Timeter Instrument Corp. for the device "PRESET FLOWMETER". The FDA issued a decision of Substantially Equivalent on September 21, 1981. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. Timeter Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1981
- Date Received
- August 24, 1981
- 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