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FDA 510(k)

SMARTECH, MODEL HOLI I

K-Number: K050507 · 2005-07-07

ApplicantCycling and Health Tech. Industry R&D Center
Decision Date2005-07-07
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SMARTECH, MODEL HOLI I is the device name listed in this FDA 510(k) record. The listed applicant is Cycling and Health Tech. Industry R&D Center. It received FDA 510(k) clearance on 2005-07-07 under 510(k) number K050507. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTECH, MODEL HOLI I?

SMARTECH, MODEL HOLI I is a medical device that received FDA 510(k) clearance on 2005-07-07. The listed applicant is Cycling and Health Tech. Industry R&D Center. The 510(k) number is K050507.

When did SMARTECH, MODEL HOLI I receive FDA 510(k) clearance?

SMARTECH, MODEL HOLI I received FDA 510(k) clearance on 2005-07-07, under 510(k) number K050507.

Who is the listed applicant for SMARTECH, MODEL HOLI I?

The FDA 510(k) record lists Cycling and Health Tech. Industry R&D Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTECH, MODEL HOLI I?

The FDA product code for SMARTECH, MODEL HOLI I is INI.

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Other records listing Cycling and Health Tech. Industry R&D Center as applicant

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Related Devices (Code: INI)

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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.

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