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510(k) K081035

AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 by Osypka Medical, Inc. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2008
Date Received
April 11, 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

Other clearances by Osypka Medical, Inc.

  • K123916 — PSA SERIES (April 9, 2013)
  • K082242 — ICON, MODEL C3 (October 8, 2008)
  • K070985 — AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC (February 1, 2008)
  • K033130 — PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR (October 31, 2003)
  • 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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