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510(k) K905568

TOPICAL COOLING PAD, MODEL 7000 by Daily Medical Products, Inc. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1991
Date Received
December 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat-Exchanger, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4240
Review Panel
CV
Submission Type

Other clearances by Daily Medical Products, Inc.

  • K914005 — FIBEROPTIC TYMPANIC THERMOMETER, MODEL 6000 (July 30, 1992)
  • K905652 — MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000 (February 14, 1991)
  • K896975 — CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 (February 5, 1990)
  • K896971 — CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 (February 5, 1990)
  • K896974 — CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 (February 5, 1990)
  • K896972 — CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 (February 5, 1990)
  • K896973 — CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 (February 5, 1990)

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