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510(k) K924997

EDD by Arc Medical, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1995
Date Received
October 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Arc Medical, Inc.

  • K090738 — THERMOFLO HCH, THERMOFLO FILTER (July 27, 2009)
  • K063125 — FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) (April 13, 2007)
  • K011212 — FILTERFLO H (December 20, 2001)
  • K982239 — CIRCUIT GUARD (August 14, 1998)
  • K924627 — XTEND CIRCUITS (TM) (April 7, 1993)

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