510(k) K822746
K822746 is an FDA 510(k) premarket notification submitted by Timeter Instrument Corp. for the device "RT-200 CALIBRATION ANALYZER". The FDA issued a decision of Substantially Equivalent on October 13, 1982. The device falls under product code BXX (Calibrator, Pressure, Gas), a Class I device regulated under 21 CFR 868.2620. Timeter Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1982
- Date Received
- September 10, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Pressure, Gas
- Device Class
- Class I
- Regulation Number
- 868.2620
- Review Panel
- AN
- Submission Type