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510(k) K030517

BALL RECORDING ELECTRODE/STIMULATION PROBE by Viasys Healthcare, Inc. — Product Code GZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2003
Date Received
February 19, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Nasopharyngeal
Device Class
Class II
Regulation Number
882.1340
Review Panel
NE
Submission Type

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  • 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)

Other clearances for product code GZK

  • K830325 — TIGER PULSE (March 1, 1983)