510(k) K922052
K922052 is an FDA 510(k) premarket notification submitted by Medoc Corp. for the device "TSA 2001 THERMAL SENSORY ANALYZER". The FDA issued a decision of Substantially Equivalent on October 21, 1993. The device falls under product code LQW (Test, Temperature Discrimination), a Class I device regulated under 21 CFR 882.1200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1993
- Date Received
- May 4, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Temperature Discrimination
- Device Class
- Class I
- Regulation Number
- 882.1200
- Review Panel
- NE
- Submission Type