K062137 is an FDA 510(k) clearance for the MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on August 24, 2006, 29 days after receiving the submission on July 26, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K062137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2006 |
| Decision Date | August 24, 2006 |
| Days to Decision | 29 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 |