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510(k) K982943

TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 by Transtracheal Systems — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1999
Date Received
August 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Transtracheal Systems

  • K981078 — TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 (July 23, 1998)
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  • K962944 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) (October 23, 1996)
  • K904749 — TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 (March 1, 1991)
  • K904748 — TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 (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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