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510(k) K200717

CLEWICU System (ClewICUServer and ClewICUnitor) by Clew Medical , Ltd. — Product Code QNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2021
Date Received
March 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Medium-Term Adjunctive Predictive Cardiovascular Indicator
Device Class
Class II
Regulation Number
870.2210
Review Panel
CV
Submission Type

The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

Other clearances by Clew Medical , Ltd.

  • K233216 — CLEWICU System (January 13, 2024)

Other clearances for product code QNL

  • K233253 — eCARTv5 Clinical Deterioration Suite (“eCART”) (June 21, 2024)
  • K233216 — CLEWICU System (January 13, 2024)
  • K230842 — SignalHF (IM008) (October 25, 2023)
  • K231038 — Global Hypoperfusion Index (GHI) Algorithm (July 26, 2023)