Submission Details
| 510(k) Number | K150190 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 27, 2015 |
| Decision Date | February 26, 2015 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Special
IntraTemp Solution Warmer
Feb 2015
Decision
30d
Days
Class 1
Risk
About This 510(k) Submission
K150190 is an FDA 510(k) clearance for the IntraTemp Solution Warmer, a Warmer, Irrigation Solution (Class I — General Controls, product code LHC), submitted by Ecolab, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 26, 2015, 30 days after receiving the submission on January 27, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 890.5950.
Device Classification
| Product Code | LHC — Warmer, Irrigation Solution |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5950 |
Manufacturer
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