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510(k) K884464

SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR by Spirometrics, Inc. — Product Code JAX

K884464 is an FDA 510(k) premarket notification submitted by Spirometrics, Inc. for the device "SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR". The FDA issued a decision of Substantially Equivalent on January 19, 1989. The device falls under product code JAX (Pneumotachometer), a Class II device regulated under 21 CFR 868.2550. Spirometrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1989
Date Received
October 24, 1988
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 Spirometrics, Inc.

  • K915059 — PEAK FLOW MONITOR (July 27, 1992)
  • K911358 — CMD/DLCO DIAGNOSTIC SPIROMETER (July 22, 1991)
  • K900322 — CO/CMD-1 (April 30, 1990)
  • K901057 — SPIROMETRICS MODEL 2600 MIRO SPIROMETER (April 3, 1990)
  • K900673 — SERIAL FLOW (April 3, 1990)
  • K884465 — SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM) (November 9, 1988)
  • K863953 — SPIROMETRICS MODEL 2500 FLOWMATE(TM) (January 15, 1987)
  • K850045 — SPIROMETRICS 2453 & SMI III (February 14, 1985)
  • K844333 — SPIROMETRICS 2451 & SMI I (November 20, 1984)
  • K831497 — SPIROMETRICS BREON 2400 & SMI 2400 (June 24, 1983)

Other clearances for product code JAX

  • K990962 — FLOSENSE, MODEL 29-8010 (January 7, 2000)
  • K921178 — PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS (August 26, 1992)
  • 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