510(k) K771847
K771847 is an FDA 510(k) premarket notification submitted by Jablecki, Charles, Dr. for the device "TEMP-TESTER". The FDA issued a decision of Substantially Equivalent on November 2, 1977. The device falls under product code GXB (Esthesiometer), a Class I device regulated under 21 CFR 882.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 1977
- Date Received
- September 28, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esthesiometer
- Device Class
- Class I
- Regulation Number
- 882.1500
- Review Panel
- NE
- Submission Type