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510(k) K223170

Electronic Blood Pressure Monitor, model: HTD6602US by Hetaida Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2023
Date Received
October 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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  • K180387 — Infrared Ear Thermometer (January 10, 2019)
  • K171888 — Non-contact infrared body thermometer (July 23, 2018)
  • K180385 — Infrared Body Thermometer (May 11, 2018)

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