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510(k) K932812

EC 5R PLETHYSMOGRAPH by D. E. Hokanson, Inc. — Product Code JEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1994
Date Received
June 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Volume
Device Class
Class II
Regulation Number
868.1760
Review Panel
AN
Submission Type

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  • K932851 — DISPOSABLE PENILE BLOOD PRESSURE CUFFS (November 15, 1993)
  • K905367 — E-20 RAPID CUFF INFLATOR (March 6, 1991)
  • K901592 — MODEL MD-5 DOPPLER (October 22, 1990)

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