510(k) K792060

TEMPTRONIC 100 WATER BATH by Sybron Corp. — Product Code JTQ

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