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510(k) K033939

FLOSENSE II, MODEL 29-8040 by Sdi Diagnostics, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2004
Date Received
December 15, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

Other clearances by Sdi Diagnostics, Inc.

  • K150515 — IQSense Flow Sensor Mouthpiece (January 12, 2016)
  • K092813 — ASTRASONIC SPIROMETER, MODEL 29-8000 (July 16, 2010)
  • K061571 — ASTRA 300 (January 31, 2007)
  • K062913 — ASTRAGUARD PULMONARY FUNCTION FILTER (January 26, 2007)
  • K031643 — SPIROTEL, MODEL 29-1020 (December 9, 2003)
  • K013812 — SPIROLAB II, MODEL 29 (February 11, 2002)
  • K011470 — SDI SB OFFICE, MODEL 29- (October 12, 2001)
  • K990962 — FLOSENSE, MODEL 29-8010 (January 7, 2000)
  • K934509 — PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER (October 21, 1993)

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