K923066 is an FDA 510(k) clearance for the FLO-GARD 2100 - 2M8281M. This device is classified as a Pump, Infusion, Enteral (Class II - Special Controls, product code LZH).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 13, 1993, 322 days after receiving the submission on June 25, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K923066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1992 |
| Decision Date | May 13, 1993 |
| Days to Decision | 322 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZH — Pump, Infusion, Enteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |