Decision Date2012-05-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
HIGH FIVE is the device name listed in this FDA 510(k) record. The listed applicant is Central Medicare Sdn Bhd. It received FDA 510(k) clearance on 2012-05-23 under 510(k) number K113440. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HIGH FIVE?
HIGH FIVE is a medical device that received FDA 510(k) clearance on 2012-05-23. The listed applicant is Central Medicare Sdn Bhd. The 510(k) number is K113440.
When did HIGH FIVE receive FDA 510(k) clearance?
HIGH FIVE received FDA 510(k) clearance on 2012-05-23, under 510(k) number K113440.
Who is the listed applicant for HIGH FIVE?
The FDA 510(k) record lists Central Medicare Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HIGH FIVE?
The FDA product code for HIGH FIVE is LZA.
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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.