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510(k) K033197

INOGEN SATELLITE CONSERVER by Medical Electronic Devices, Inc. — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2004
Date Received
October 2, 2003
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

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  • K983601 — DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC (December 15, 1998)
  • K983459 — PULSED OXYGEN CONSERVING DEVICE, POCD (December 8, 1998)
  • K770115 — ARTERIAL DIAGNOSTIC UNIT (ADU) (February 1, 1977)
  • K761092 — INGUINAL COMPRESSIVE DEVICE (ICD) (December 16, 1976)

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