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510(k) K173772

BreathID Hp System by Exalenz Bioscience , Ltd. — Product Code MSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2018
Date Received
December 12, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Urea (Breath Or Blood)
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Other clearances by Exalenz Bioscience , Ltd.

  • K193610 — BreathID Smart System (February 6, 2020)
  • K173777 — BreathID Hp Lab System (March 8, 2018)
  • K162150 — BreathID Hp Lab System (October 31, 2016)
  • K130524 — BREATHID HP SYSTEM (May 22, 2013)

Other clearances for product code MSQ

  • K221896 — BreathID Hp System (December 19, 2022)
  • K223185 — BreathID® Smart System (November 10, 2022)
  • K220494 — BreathID Hp Lab System, BreathID Smart System (June 23, 2022)
  • K193610 — BreathID Smart System (February 6, 2020)
  • K173777 — BreathID Hp Lab System (March 8, 2018)
  • K162150 — BreathID Hp Lab System (October 31, 2016)
  • K130524 — BREATHID HP SYSTEM (May 22, 2013)
  • K093834 — CRIT-LINE ANEMIA MANAGEMENT SOFTWARE (September 29, 2010)
  • K092817 — POC-AS10 AUTO SAMPLER (March 9, 2010)
  • K041148 — POCONE INFRARED SPECTROPHOTOMETER (July 15, 2004)