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510(k) K171241

Pulse Oximeter by Hunan Accurate Bio-Medical Technology Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2018
Date Received
April 27, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Hunan Accurate Bio-Medical Technology Co., Ltd.

  • K243049 — Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) (January 2, 2025)
  • K240808 — Pulse Oximeter (WS20A) (October 3, 2024)
  • K141105 — PULSE OXIMETER (December 4, 2014)

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