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FDA 510(k)

SMARTLANK WIRELESS, MODEL 001970

K-Number: K033642 · 2004-05-25

ApplicantMrl, A Welch Allyn Company
Decision Date2004-05-25
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMARTLANK WIRELESS, MODEL 001970 is the device name listed in this FDA 510(k) record. The listed applicant is Mrl, A Welch Allyn Company. It received FDA 510(k) clearance on 2004-05-25 under 510(k) number K033642. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTLANK WIRELESS, MODEL 001970?

SMARTLANK WIRELESS, MODEL 001970 is a medical device that received FDA 510(k) clearance on 2004-05-25. The listed applicant is Mrl, A Welch Allyn Company. The 510(k) number is K033642.

When did SMARTLANK WIRELESS, MODEL 001970 receive FDA 510(k) clearance?

SMARTLANK WIRELESS, MODEL 001970 received FDA 510(k) clearance on 2004-05-25, under 510(k) number K033642.

Who is the listed applicant for SMARTLANK WIRELESS, MODEL 001970?

The FDA 510(k) record lists Mrl, A Welch Allyn Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTLANK WIRELESS, MODEL 001970?

The FDA product code for SMARTLANK WIRELESS, MODEL 001970 is MKJ. This falls under the Dental category.

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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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