PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
FDA 510(k) clearance K140535 · decided 2014-11-25
Clearance details
- K-number
- K140535
- Device name
- PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
- Applicant
- Philips Medizin Systeme Boblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2014-03-04
- Decision date
- 2014-11-25
- Days to decision
- 266 days
- Clearance type
- Abbreviated
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Boeblingen, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medizin Systeme Boblingen 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 Fetal Monitor, FM20, Part number M2702A, Part M2703A recall (Z-2522-2026) | Philips North America Llc | 2026-06-22 |
| Philips Avalon Fetal Monitor, FM 30 Part numberM2703A recall (Z-2523-2026) | Philips North America Llc | 2026-06-22 |
| Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart an recall (Z-2239-2024) | Philips North America Llc | 2024-06-28 |