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510(k) K200986

OPTI® B-Lac Cassette by Opti Medical Systems, Inc. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2021
Date Received
April 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type

Other clearances by Opti Medical Systems, Inc.

  • K131126 — OPTI CCA-TS2 (August 22, 2013)
  • K093280 — OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 (January 7, 2011)

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