510(k) K792060
K792060 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "TEMPTRONIC 100 WATER BATH". The FDA issued a decision of Substantially Equivalent on December 4, 1979. The device falls under product code JTQ (Bath, Incubators/Water, All), a Class I device regulated under 21 CFR 866.2540. Sybron Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1979
- Date Received
- October 15, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bath, Incubators/Water, All
- Device Class
- Class I
- Regulation Number
- 866.2540
- Review Panel
- MI
- Submission Type