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510(k) K890342

AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) by Eastmed Enterprises, Inc. — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by Eastmed Enterprises, Inc.

  • K922019 — LARYNGOSCOPE RIGID (January 26, 1993)
  • K921128 — ENDOTRACHEAL TUBE STYLET (June 2, 1992)
  • K914741 — AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED (February 3, 1992)
  • K903618 — ROBERTAZZI NASOPHARYNGEAL AIRWAY (January 8, 1991)
  • K901489 — MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE) (April 10, 1990)
  • K884584 — TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS (November 14, 1988)
  • K884073 — LARYNGOSCOPE BLADE (ROBERTSHAW STYLE) (October 13, 1988)
  • K884072 — 15 MILLIMETER MALE AND FEMALE ADAPTERS (October 7, 1988)
  • K882433 — LARYNGOSCOPE RIGID (September 2, 1988)
  • K882434 — MASK, GAS, ANESTHETIC (June 30, 1988)

Other clearances for product code BTO

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  • K192511 — Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy (July 22, 2020)
  • K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestr (April 10, 2018)
  • K120079 — PRIMED TRACHEOSTOMY TUBES (MULTIPLE) (May 24, 2012)
  • K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (March 24, 2011)
  • K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (July 13, 2010)
  • K100480 — ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH (June 11, 2010)
  • K100283 — VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PRE (April 23, 2010)
  • K083031 — PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (August 18, 2009)