The following data is part of a premarket notification filed by Ecolab Inc. with the FDA for Intratemp Solution Warmer.
| Device ID | K150190 |
| 510k Number | K150190 |
| Device Name: | IntraTemp Solution Warmer |
| Classification | Warmer, Irrigation Solution |
| Applicant | Ecolab Inc. 370 Wabasha Street North St. Paul, MN 55102 -1390 |
| Contact | Michelle Nivala |
| Correspondent | Michelle Nivala Ecolab Inc. 370 Wabasha Street North St. Paul, MN 55102 -1390 |
| Product Code | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-27 |
| Decision Date | 2015-02-26 |