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FDA 510(k)

CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control

K-Number: K182882 · 2018-11-14

ApplicantConmed Corporation
Decision Date2018-11-14
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K182882. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control?

CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Conmed Corporation. The 510(k) number is K182882.

When did CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control receive FDA 510(k) clearance?

CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control received FDA 510(k) clearance on 2018-11-14, under 510(k) number K182882.

Who is the listed applicant for CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control?

The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control?

The FDA product code for CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control is HRX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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