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510(k) K990556

ESOPHAGEAL INTUBATION DETECTOR by Wolfe Tory Medical, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1999
Date Received
February 22, 1999
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 Wolfe Tory Medical, Inc.

  • K021044 — MADETT (September 11, 2002)
  • K002255 — LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) (September 18, 2000)
  • K945745 — ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER) (December 7, 1994)
  • K942628 — ESOPHAGEAL INTUBATION DETECTOR BULB (August 18, 1994)

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