K123729 is an FDA 510(k) clearance for the VERSARATE FLOW RATE CONTROLER. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Emed Technologies Corporation (El Dorado Hills, US). The FDA issued a Cleared decision on December 21, 2012, 16 days after receiving the submission on December 5, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K123729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2012 |
| Decision Date | December 21, 2012 |
| Days to Decision | 16 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 |