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Product Classification

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Device

culdoscope (and accessories)

Regulation Description

Culdoscope and accessories.

Regulation Medical Specialty

Obstetrics/Gynecology

Review Panel

Obstetrics/Gynecology

Product Code

HEW

Submission Type

510(k)

Regulation Number

884.1640

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

IEC 60601-2-18 (1996) Amendment 1 2000 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
ISO 8600-4 First edition 1997-07-01 Optics and optical instruments -- Medical endoscopes and certain accessories -- Part 4: Determination of maximum width of insertion portion
ISO 8600-1 Second edition 2005-05-01 Optics and photonics -- Medical endoscopes and endotherapy devices -- Part 1: General requirements
ISO 8600-5 First edition 2005-03-15 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
ISO 8600-6 First edition 2005-03-15 Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
ISO 8600-3 First edition 1997-07-01 Optics and Optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
ISO 8600-3 First edition 1997-07-01 AMENDMENT 1 Optics and optical instruments - Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics`
IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Third Party Review

Not Third Party Eligible

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