PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
FDA 510(k) clearance K111083 · decided 2011-08-17
Clearance details
- K-number
- K111083
- Device name
- PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decision
- Substantially Equivalent
- Date received
- 2011-04-19
- Decision date
- 2011-08-17
- Days to decision
- 120 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
+ Add to Predicate Builder ◉ Watch Philips Medizinsysteme Boeblingen GmbH
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M recall (Z-0105-2015) | Philips Medical Systems, Inc. | 2014-10-21 |