K070438 is an FDA 510(k) clearance for the MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305. This device is classified as a Accessories, Pump, Infusion (Class II - Special Controls, product code MRZ).
Submitted by Medtronic Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on October 17, 2007, 244 days after receiving the submission on February 15, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K070438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2007 |
| Decision Date | October 17, 2007 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MRZ — Accessories, Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |