Devices

Philips Avalon Monitors

Model / Serial
software revision J.30.58:
Product Classification
Obstetrical and Gynecological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.
Product Description
Philips Avalon Monitors with software revision J.30.58: || Model Product || FM20 M2702A ; || FM30 M2703A ; || FM50 M2705A || Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
Manufacturer
Philips Medical Systems, Inc.
1 Event
- Recall of Philips Avalon Monitors

Manufacturer

Philips Medical Systems, Inc.

Manufacturer Address
Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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