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510(k) K780422

PINWHEEL by Projects IN Health — Product Code GWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1978
Date Received
March 17, 1978
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 by Projects IN Health

  • K781224 — METER, FLOW, PEAK (October 15, 1978)
  • K770580 — PEAK FLOW METER (August 4, 1977)

Other clearances for product code GWY

  • K050313 — BIS SRS (SEMI-RESUABLE SENSOR) (February 24, 2005)
  • K942926 — NEURO-AIDE (August 3, 1994)
  • K871167 — SENSITESTER (April 1, 1987)
  • K851749 — 1-380 PINWHEEL (WARTENBERG) (June 13, 1985)