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510(k) K212143

Neteera 130H/131H Vital Sign Monitoring Sensor by Neteera Technologies , Ltd. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2022
Date Received
July 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Neteera Technologies , Ltd.

  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)

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  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)
  • K202464 — Vital Sign Monitoring Sensor (Model :XK300) (April 26, 2021)
  • K181165 — Philips wearable biosensor-G5 Solution (March 7, 2019)