K073221 is an FDA 510(k) clearance for the CADENCE II. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on December 28, 2007, 43 days after receiving the submission on November 15, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K073221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2007 |
| Decision Date | December 28, 2007 |
| Days to Decision | 43 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | HGM — System, Monitoring, Perinatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2740 |