GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT— 510(k) K941662

Name: FDA 510(k) clearance K941662
Creator: U.S. Food and Drug Administration
Published: 1994-07-20

Substantially Equivalent

Gm Engineering, Inc.

FDA 510(k) clearance K941662 for GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT, Substantially Equivalent on 1994-07-20. Applicant: Gm Engineering, Inc.. Device class: 1.

Clearance details

Applicant: Gm Engineering, Inc.
Product code: Code EQH
Device class: Class 1
Regulation: 21 CFR 874.4350
Advisory panel: Ear, Nose, Throat
Date received: 1994-04-05
Decision date: 1994-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Verne, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EQH

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K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT1995-12-04
K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE1995-11-13
K951829 — COLD LIGHT SOURCE LOS 1501995-07-10
K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE1994-08-24
K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT1994-08-23

More clearances from Gm Engineering, Inc.

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K953348 — ARTICULATING RETRACTOR TISSUE RETRACTORS1995-09-12
K942626 — CONTINUOUS FLOW BIOPSY PROBE1995-05-30
K932394 — BERNSTEIN(TM) UTERINE MANIPULATOR1995-01-26
K942703 — GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA1994-08-19
K941660 — GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT1994-05-24

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