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510(k) K833012

INSPIROMETER by Kinetix — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1983
Date Received
September 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

Other clearances by Kinetix

  • K832401 — RESPIROMETER (April 30, 1984)
  • K840459 — IMPROVED MOUTHPIECE (February 17, 1984)
  • K833420 — KINETIX MOUTHPIECE (January 10, 1984)

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