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510(k) K871167

SENSITESTER by Dexin Pty. , Ltd. — Product Code GWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1987
Date Received
March 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pinwheel
Device Class
Class I
Regulation Number
882.1750
Review Panel
NE
Submission Type

Other clearances for product code GWY

  • K050313 — BIS SRS (SEMI-RESUABLE SENSOR) (February 24, 2005)
  • K942926 — NEURO-AIDE (August 3, 1994)
  • K851749 — 1-380 PINWHEEL (WARTENBERG) (June 13, 1985)
  • K780422 — PINWHEEL (April 4, 1978)