K082369 is an FDA 510(k) clearance for the CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR. 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 November 7, 2008, 81 days after receiving the submission on August 18, 2008.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K082369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2008 |
| Decision Date | November 07, 2008 |
| Days to Decision | 81 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGM — System, Monitoring, Perinatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2740 |