510(k) K831995
K831995 is an FDA 510(k) premarket notification submitted by Gabriel Ent. for the device "TRENDO-SCOPE". The FDA issued a decision of Substantially Equivalent on Aug 8, 1983. The device falls under product code HCS (Device, Temperature Measurement, Direct Contact, Powered), a Class II device regulated under 21 CFR 882.1570. Gabriel Ent. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 8, 1983
- Date Received
- Jun 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Device, Temperature Measurement, Direct Contact, Powered
- Device Class
- Class II
- Regulation Number
- 882.1570
- Review Panel
- NE
- Submission Type
- 510(k)