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510(k) K942628

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1994
Date Received
June 2, 1994
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)
  • K990556 — ESOPHAGEAL INTUBATION DETECTOR (March 26, 1999)
  • K945745 — ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER) (December 7, 1994)

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