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510(k) K082242

ICON, MODEL C3 by Osypka Medical, Inc. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2008
Date Received
August 7, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

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  • K022939 — OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES, (October 3, 2002)
  • K020896 — OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MOD (June 14, 2002)

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