510(k) K915831

THERMAL PROBE COVER by Vermont Medical, Inc. — Product Code FMT

K915831 is an FDA 510(k) premarket notification submitted by Vermont Medical, Inc. for the device "THERMAL PROBE COVER". The FDA issued a decision of Substantially Equivalent on June 8, 1992. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Vermont Medical, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1992
Date Received
December 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type