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510(k) K070614

CORSCREEN by Viasys Healthcare GmbH — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2007
Date Received
March 5, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Viasys Healthcare GmbH

  • K092324 — SPIROPRO (September 3, 2009)
  • K091412 — CLEAN PEAK FLOW METER (August 21, 2009)
  • K091505 — COR12+ (June 10, 2009)
  • K081823 — MASTERSCREEN PAED - BABY BODY (May 18, 2009)
  • K080510 — VIP PULMONARY FUNCTION SYSTEM (August 20, 2008)
  • K080734 — FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT (June 26, 2008)
  • K072061 — MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (April 22, 2008)
  • K072323 — MASTERSCREEN & OXYCON CPX (October 10, 2007)
  • K071753 — MASTERSCREEN PNEUMO & MASTERSCOPE (August 14, 2007)
  • K062011 — MODIFICATION TO FLOWSCREEN (May 11, 2007)

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