K942271 is an FDA 510(k) clearance for the LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Level 1 Technologies, Inc. (Rockland, US). The FDA issued a Cleared decision on July 12, 1995, 428 days after receiving the submission on May 10, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K942271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1994 |
| Decision Date | July 12, 1995 |
| Days to Decision | 428 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 |