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510(k) K990962

FLOSENSE, MODEL 29-8010 by Sdi Diagnostics, Inc. — Product Code JAX

K990962 is an FDA 510(k) premarket notification submitted by Sdi Diagnostics, Inc. for the device "FLOSENSE, MODEL 29-8010". The FDA issued a decision of Substantially Equivalent on January 7, 2000. The device falls under product code JAX (Pneumotachometer), a Class II device regulated under 21 CFR 868.2550. Sdi Diagnostics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2000
Date Received
March 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pneumotachometer
Device Class
Class II
Regulation Number
868.2550
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)
  • K033939 — FLOSENSE II, MODEL 29-8040 (January 30, 2004)
  • 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)
  • K934509 — PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER (October 21, 1993)

Other clearances for product code JAX

  • K921178 — PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS (August 26, 1992)
  • K884464 — SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR (January 19, 1989)
  • K853085 — PAX METER (September 3, 1985)
  • K833265 — RESPIRATORY FLOW MODULE (November 28, 1983)
  • K812825 — FLO-COR I (October 26, 1981)
  • K791730 — RING-ORIFICE, TURBULENT FLOW PNEUMOT (November 16, 1979)
  • K770061 — VO RESPIRATORY PNEUMOTACHOGRAPH (January 14, 1977)

FDA data resources