FDA 510(k)

DOSE 1

K-Number: K000209 · 2000-08-18

ApplicantScanditronix Wellhofer North America

Decision Date2000-08-18

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DOSE 1 is the device name listed in this FDA 510(k) record. The listed applicant is Scanditronix Wellhofer North America. It received FDA 510(k) clearance on 2000-08-18 under 510(k) number K000209. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOSE 1?

DOSE 1 is a medical device that received FDA 510(k) clearance on 2000-08-18. The listed applicant is Scanditronix Wellhofer North America. The 510(k) number is K000209.

When did DOSE 1 receive FDA 510(k) clearance?

DOSE 1 received FDA 510(k) clearance on 2000-08-18, under 510(k) number K000209.

Who is the listed applicant for DOSE 1?

The FDA 510(k) record lists Scanditronix Wellhofer North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOSE 1?

The FDA product code for DOSE 1 is IYE.

Related Devices (Code: IYE)

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Official Source

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