K061197 is an FDA 510(k) clearance for the KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Kawasumi Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on June 30, 2006, 63 days after receiving the submission on April 28, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K061197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2006 |
| Decision Date | June 30, 2006 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE — Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |