AspenMed+
K-Number: K213076 · 2021-12-20
ApplicantAspen Glove Sdn. Bhd.
Decision Date2021-12-20
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
AspenMed+ is a medical device manufactured by Aspen Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2021-12-20 under approval number K213076. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AspenMed+?
AspenMed+ is a medical device that received FDA 510(k) clearance on 2021-12-20. It is manufactured by Aspen Glove Sdn. Bhd.. The 510(k) number is K213076.
When was AspenMed+ approved by the FDA?
AspenMed+ received FDA 510(k) clearance on 2021-12-20, under approval number K213076.
What company makes AspenMed+?
AspenMed+ is manufactured by Aspen Glove Sdn. Bhd..
What is the FDA product code for AspenMed+?
The FDA product code for AspenMed+ is LZC.
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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.