K942181 is an FDA 510(k) clearance for the SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on July 14, 1994, 71 days after receiving the submission on May 4, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K942181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1994 |
| Decision Date | July 14, 1994 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |