PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
FDA 510(k) clearance K092028 · decided 2010-02-17
Clearance details
- K-number
- K092028
- Device name
- PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2009-07-06
- Decision date
- 2010-02-17
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Boeblingen, Bw, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.