510(k) K142173
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