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510(k) DEN160020

CipherOx CRI Tablet by Flashback Technologies, Inc. — Product Code PPW

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 21, 2016
Date Received
May 24, 2016
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adjunctive Cardiovascular Status Indicator
Device Class
Class II
Regulation Number
870.2200
Review Panel
CV
Submission Type

The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). 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 Flashback Technologies, Inc.

  • K213255 — CipherOx CRI Tablet (June 17, 2022)
  • K173929 — CipherOx CRI M1 (July 24, 2018)

Other clearances for product code PPW

  • K252204 — prolaio eVO2peak Module (Version 1.0) (December 16, 2025)
  • K241479 — Etiometry Platform (DAV 5.4 RAE 9.2) (February 12, 2025)
  • K223578 — T3 Platform software (July 7, 2023)
  • K213230 — T3 Platform Software (June 22, 2022)
  • K213255 — CipherOx CRI Tablet (June 17, 2022)
  • K173929 — CipherOx CRI M1 (July 24, 2018)