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510(k) K091505

COR12+ by Viasys Healthcare GmbH — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2009
Date Received
May 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Viasys Healthcare GmbH

  • K092324 — SPIROPRO (September 3, 2009)
  • K091412 — CLEAN PEAK FLOW METER (August 21, 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)
  • K070614 — CORSCREEN (May 4, 2007)

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