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510(k) K052563

INOGEN SATELLITE CONSERVER, MODEL SC-100 by Medical Electronic Devices, Inc. — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2005
Date Received
September 19, 2005
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 Medical Electronic Devices, Inc.

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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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