510(k) K871167
K871167 is an FDA 510(k) premarket notification submitted by Dexin Pty. , Ltd. for the device "SENSITESTER". The FDA issued a decision of Substantially Equivalent on Apr 1, 1987. The device falls under product code GWY (Pinwheel), a Class I device regulated under 21 CFR 882.1750.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 1, 1987
- Date Received
- Mar 24, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pinwheel
- Device Class
- Class I
- Regulation Number
- 882.1750
- Review Panel
- NE
- Submission Type
- 510(k) Exempt