Isansys Lifetemp Sensor - Medium

• FDA 510(k) K172329 decided 23 Apr 2018 Active
• FDA GUDID UDI-DI 05060488680021 listed 26 Apr 2024 Listed

1. 23 Apr 2018 Cleared FDA 510(k) K172329
2. 26 Apr 2024 Listed FDA GUDID 05060488680021

Trade name

Isansys

Generic name

Physiological measuring device wireless data capture/transfer unit

Model / Ref / Catalog

Lifetemp Sensor - Medium

Primary DI / UDI-DI

05060488680021

510(k) Number

K172329 ↗

FDA product code

DRG

GMDN term

Physiological measuring device wireless data capture/transfer unit

Device class

Class II

Regulation number

870.2910

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Category: Physiological measuring device wireless data capture/transfer unit

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• Isansys Patient Gateway T510 - 10.1 - WiFi

  Class II

  CE/MDR FDA 510(k) K172329 Active Cleared 23 Apr 2018 +1authorizations

• Isansys Patient Gateway SM-X200 – 10.5 - WiFi

  Class II

  CE/MDR FDA 510(k) K172329 Active Cleared 23 Apr 2018 +1authorizations

• Isansys Lifetemp Sensor - Large

  Class II

  FDA 510(k) K172329 Active Cleared 23 Apr 2018 GUDID on market