← Back to catalogue
Modification To Philips Avalon Fetal Monitors Fm20 And Fm30
FDA 510(k)Class II (US FDA 510(k))
510(k) K062137
Identifiers
- 510(k) Number
- K062137 FDA 510(k)
- FDA Product Code
- HGM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2740 FDA 510(k)
- Regulation Number
- 884.2740 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Modification To Philips Avalon Fetal Monitors Fm20 And Fm30 by Philips Medizin Systeme Boeblingen GmbH — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062137 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medizin Systeme Boeblingen GmbH
Sources (1)
- FDA 510(k) K062137 24 fields · synced Jun 18, 2026