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510(k) K131509

ZOE FLUID STATUS MONITOR by Noninvasive Medical Technologies, Inc. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2013
Date Received
May 24, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

Other clearances by Noninvasive Medical Technologies, Inc.

  • K133301 — ZOE FLUID STATUS MONITOR (January 22, 2014)
  • K112830 — ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) (November 13, 2012)
  • K042113 — ZOE FLUID STATUS MONITOR (September 14, 2004)

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