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510(k) K832177

PULSAIR MODEL SP-1 by Thermowave Medical Device Corp. — Product Code IRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1983
Date Received
July 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Heating, Powered
Device Class
Class I
Regulation Number
890.5950
Review Panel
PM
Submission Type

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  • K861340 — R1750 AND R1424 POWERED HEATING UNITS (May 2, 1986)
  • K801625 — THERMOLATOR HEATING UNIT (July 28, 1980)