K231893 is an FDA 510(k) clearance for the LOWTEM Crystal 120. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by Lowtem Co., Ltd. (Daegu-Si, KR). The FDA issued a Cleared decision on September 18, 2024, 448 days after receiving the submission on June 28, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K231893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2023 |
| Decision Date | September 18, 2024 |
| Days to Decision | 448 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MLR - Sterilizer, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |