K213191 is an FDA 510(k) clearance for the S-Line. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Barkey GmbH & Co. KG (Leopoldshoehe, DE). The FDA issued a Cleared decision on May 24, 2022, 237 days after receiving the submission on September 29, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K213191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | May 24, 2022 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LGZ — Warmer, Thermal, Infusion Fluid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |