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510(k) K223291

Electronic Blood Pressure Monitor by Shenzhen Pango Medical Electronics Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2023
Date Received
October 26, 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

Other clearances by Shenzhen Pango Medical Electronics Co., Ltd.

  • K240729 — Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-80 (June 14, 2024)
  • K212346 — Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 (May 5, 2022)

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