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FDA 510(k)

GALAXY SYSTEM; JUPITER

K-Number: K111055 · 2011-12-21

ApplicantPersonal Health Institute International
Decision Date2011-12-21
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GALAXY SYSTEM; JUPITER is the device name listed in this FDA 510(k) record. The listed applicant is Personal Health Institute International. It received FDA 510(k) clearance on 2011-12-21 under 510(k) number K111055. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALAXY SYSTEM; JUPITER?

GALAXY SYSTEM; JUPITER is a medical device that received FDA 510(k) clearance on 2011-12-21. The listed applicant is Personal Health Institute International. The 510(k) number is K111055.

When did GALAXY SYSTEM; JUPITER receive FDA 510(k) clearance?

GALAXY SYSTEM; JUPITER received FDA 510(k) clearance on 2011-12-21, under 510(k) number K111055.

Who is the listed applicant for GALAXY SYSTEM; JUPITER?

The FDA 510(k) record lists Personal Health Institute International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GALAXY SYSTEM; JUPITER?

The FDA product code for GALAXY SYSTEM; JUPITER is OLV.

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Official Source

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