K970359 is an FDA 510(k) clearance for the COMBIPROT EMERGENCY ENFUSION DEVICE. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 18, 1997, 46 days after receiving the submission on January 31, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K970359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1997 |
| Decision Date | March 18, 1997 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |