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510(k) K060321

ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK by American Diagnostic Corp. — Product Code DQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2006
Date Received
February 9, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Electronic
Device Class
Class II
Regulation Number
870.1875
Review Panel
CV
Submission Type

Other clearances by American Diagnostic Corp.

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  • K012304 — ADC 656 ELECTRONIC STETHOSCOPE (November 1, 2001)
  • K962655 — ANEROID AND MERCURIAL SPHYGMOMANOMETERS (January 27, 1997)
  • K940686 — ELECTRONIC THERMOMETERS (July 8, 1994)
  • K935944 — PROSCOPES AND ADSCOPES (March 3, 1994)
  • K932145 — COAGULATION REFERENCE PLASMA, NORMAL (October 18, 1993)
  • K894169 — BIOTEL MICROALBUMINURIA (TM) (September 18, 1989)
  • K893608 — ACTICHROME ATIII KIT (June 23, 1989)
  • K884941 — ACTICLOT C KIT (March 13, 1989)

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