BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE— 510(k) K932771

Name: FDA 510(k) clearance K932771
Creator: U.S. Food and Drug Administration
Published: 1994-08-24

Substantially Equivalent

Xomed-Treace, Inc.

FDA 510(k) clearance K932771 for BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE, Substantially Equivalent on 1994-08-24. Applicant: Xomed-Treace, Inc.. Device class: 1.

Clearance details

Applicant: Xomed-Treace, Inc.
Product code: Code EQH
Device class: Class 1
Regulation: 21 CFR 874.4350
Advisory panel: Ear, Nose, Throat
Date received: 1993-06-08
Decision date: 1994-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Xomed-Treace, Inc.

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K940028 — ENDOSCOPE SHEATH1995-03-24
K941407 — TYMPANOSTOMY (VENTILATION) TUBE1995-03-14
K945659 — BLACKSTAR(TM) STAR SYSTEM1995-01-09
K933672 — XOMED-TREACE SCOPESHEATH1994-07-18
K934426 — NERVE INTEGRITY MONITOR-2 (NIM-2 XL)1994-05-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.