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510(k) K930533

BNOS MICROVENT(TM), MODEL AC AND MODEL AO by Bnos Meditech, Ltd. — Product Code BZT

K930533 is an FDA 510(k) premarket notification submitted by Bnos Meditech, Ltd. for the device "BNOS MICROVENT(TM), MODEL AC AND MODEL AO". The FDA issued a decision of Substantially Equivalent on March 29, 1993. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1993
Date Received
February 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Esophageal, With Electrical Conductors
Device Class
Class II
Regulation Number
868.1920
Review Panel
AN
Submission Type

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  • K111050 — ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TE (April 12, 2012)
  • K092716 — ESOPHAGEAL STETHOSCOPE (September 17, 2009)
  • K072621 — ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE (December 13, 2007)
  • K062020 — LIFESOUND ESOPHAGEAL STETHOSCOPE (September 5, 2006)
  • K982193 — ESOPHAGEAL STETHOSCOPE (September 1, 1998)
  • K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (March 19, 1998)
  • K961060 — ARISTO ESOPHAGEAL STETHOSCOPE (June 19, 1996)

FDA data resources