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510(k) K833265

RESPIRATORY FLOW MODULE by Thoratec Laboratories Corp. — Product Code JAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1983
Date Received
September 21, 1983
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

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  • K851495 — THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY (August 1, 1985)
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  • K780247 — IMPCO DISPOSABLE AORTIC PUNCH (February 27, 1978)

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)
  • K884464 — SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR (January 19, 1989)
  • K853085 — PAX METER (September 3, 1985)
  • K812825 — FLO-COR I (October 26, 1981)
  • K791730 — RING-ORIFICE, TURBULENT FLOW PNEUMOT (November 16, 1979)
  • K770061 — VO RESPIRATORY PNEUMOTACHOGRAPH (January 14, 1977)