510(k) K142173

NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE by Ecolab, Inc. — Product Code LHC

K142173 is an FDA 510(k) premarket notification submitted by Ecolab, Inc. for the device "NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE". The FDA issued a decision of Substantially Equivalent on December 30, 2014. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. Ecolab, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2014
Date Received
August 7, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Irrigation Solution
Device Class
Class I
Regulation Number
890.5950
Review Panel
HO
Submission Type