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510(k) K102442

E.S.O. (ELECTRO SENSOR OXI) by Ld Technology, LLC — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2010
Date Received
August 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • K152216 — SudoC (September 24, 2015)
  • K143152 — TM-ABI system (July 22, 2015)
  • K140412 — ANS1 SOFTWARE (May 22, 2014)
  • K131568 — SUDO PATH (June 28, 2013)
  • K130056 — PATIENT MONITOR (April 11, 2013)
  • K113264 — ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) (March 2, 2012)

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