K082765 is an FDA 510(k) clearance for the ASTOFLO PLUS. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Stihler Electronic GmbH (Sound Beach, US). The FDA issued a Cleared decision on December 18, 2008, 87 days after receiving the submission on September 22, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K082765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2008 |
| Decision Date | December 18, 2008 |
| Days to Decision | 87 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 |