FDA 510(k)

PERFORMER HT/ HANG&GO HT BASIC

K-Number: K120026 · 2012-05-08

Decision Date2012-05-08

Product CodeLGZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PERFORMER HT/ HANG&GO HT BASIC is the device name listed in this FDA 510(k) record. The listed applicant is Rand S.R.L.. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K120026. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFORMER HT/ HANG&GO HT BASIC?

PERFORMER HT/ HANG&GO HT BASIC is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Rand S.R.L.. The 510(k) number is K120026.

When did PERFORMER HT/ HANG&GO HT BASIC receive FDA 510(k) clearance?

PERFORMER HT/ HANG&GO HT BASIC received FDA 510(k) clearance on 2012-05-08, under 510(k) number K120026.

Who is the listed applicant for PERFORMER HT/ HANG&GO HT BASIC?

The FDA 510(k) record lists Rand S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERFORMER HT/ HANG&GO HT BASIC?

The FDA product code for PERFORMER HT/ HANG&GO HT BASIC is LGZ.

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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.