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510(k) K130068

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) by Essex Industries, Inc. D/B/A Essex Cryogenics of M — Product Code BYJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2013
Date Received
January 11, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Liquid-Oxygen, Portable
Device Class
Class II
Regulation Number
868.5655
Review Panel
AN
Submission Type

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  • K072723 — RESPIRONICS GOLOX (March 20, 2008)
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  • K050153 — SPIRIT, MODEL HAS (April 15, 2005)
  • K050414 — PLIX (April 11, 2005)