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FDA 510(k)

HEALTHSTAR ELITE

K-Number: K043239 · 2004-12-22

ApplicantHill Laboratories Co.
Decision Date2004-12-22
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEALTHSTAR ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Hill Laboratories Co.. It received FDA 510(k) clearance on 2004-12-22 under 510(k) number K043239. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHSTAR ELITE?

HEALTHSTAR ELITE is a medical device that received FDA 510(k) clearance on 2004-12-22. The listed applicant is Hill Laboratories Co.. The 510(k) number is K043239.

When did HEALTHSTAR ELITE receive FDA 510(k) clearance?

HEALTHSTAR ELITE received FDA 510(k) clearance on 2004-12-22, under 510(k) number K043239.

Who is the listed applicant for HEALTHSTAR ELITE?

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

What is the FDA product code for HEALTHSTAR ELITE?

The FDA product code for HEALTHSTAR ELITE is ITH.

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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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