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FDA 510(k)

HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT

K-Number: K101894 · 2011-01-21

ApplicantBioremedi Therapeutic Systems, Inc.
Decision Date2011-01-21
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioremedi Therapeutic Systems, Inc.. It received FDA 510(k) clearance on 2011-01-21 under 510(k) number K101894. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT?

HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT is a medical device that received FDA 510(k) clearance on 2011-01-21. The listed applicant is Bioremedi Therapeutic Systems, Inc.. The 510(k) number is K101894.

When did HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT receive FDA 510(k) clearance?

HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT received FDA 510(k) clearance on 2011-01-21, under 510(k) number K101894.

Who is the listed applicant for HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT?

The FDA 510(k) record lists Bioremedi Therapeutic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT?

The FDA product code for HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT is ILY.

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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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