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510(k) K981078

TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 by Transtracheal Systems — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1998
Date Received
March 24, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

Other clearances by Transtracheal Systems

  • K982943 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 (July 12, 1999)
  • K981080 — SCOOP 1 (June 17, 1998)
  • K962944 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) (October 23, 1996)
  • K904748 — TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 (March 1, 1991)
  • K904749 — TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 (March 1, 1991)
  • K902281 — MODIFIED SCOOP TRANSTRACHEAL CATHETERS (August 10, 1990)
  • K854252 — TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER (February 3, 1986)

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