K972193 is an FDA 510(k) clearance for the OLYMPIX MINI-PASTEURMATIC (58210). This device is classified as a Device, Pasteurization, Hot Water (Class II - Special Controls, product code LDS).
Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on September 5, 1997, 87 days after receiving the submission on June 10, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6991.
| 510(k) Number | K972193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1997 |
| Decision Date | September 05, 1997 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LDS — Device, Pasteurization, Hot Water |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6991 |