PHILIPS AVALON FETAL MONITORS FM20 AND FM30
FDA 510(k) clearance K071800 · decided 2007-09-27
Clearance details
- K-number
- K071800
- Device name
- PHILIPS AVALON FETAL MONITORS FM20 AND FM30
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decision
- Substantially Equivalent
- Date received
- 2007-07-02
- Decision date
- 2007-09-27
- Days to decision
- 87 days
- Clearance type
- Abbreviated
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Boeblingen, Baden-Wuerttemberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Avalon Fetal Monitor FM 20 Catalog Number: M2702A. recall (Z-0549-2010) | Philips Healthcare Inc. | 2009-12-17 |
| Philips Avalon Fetal Monitor FM 30 Catalog Number: M2703A. recall (Z-0550-2010) | Philips Healthcare Inc. | 2009-12-17 |
| Philips Avalon Fetal Monitor FM20; Model Number: M2702A. recall (Z-1478-2009) | Philips Healthcare Inc. | 2009-06-26 |
| Philips Avalon Fetal Monitor FM30; Model Number: M2703A. recall (Z-1479-2009) | Philips Healthcare Inc. | 2009-06-26 |