GM501 SpermAir and GM501 SpermActive
K-Number: K192644 · 2020-04-23
ApplicantHamilton Thorne Incorporated
Decision Date2020-04-23
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
GM501 SpermAir and GM501 SpermActive is a medical device manufactured by Hamilton Thorne Incorporated. It received FDA 510(k) clearance on 2020-04-23 under approval number K192644. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GM501 SpermAir and GM501 SpermActive?
GM501 SpermAir and GM501 SpermActive is a medical device that received FDA 510(k) clearance on 2020-04-23. It is manufactured by Hamilton Thorne Incorporated. The 510(k) number is K192644.
When was GM501 SpermAir and GM501 SpermActive approved by the FDA?
GM501 SpermAir and GM501 SpermActive received FDA 510(k) clearance on 2020-04-23, under approval number K192644.
What company makes GM501 SpermAir and GM501 SpermActive?
GM501 SpermAir and GM501 SpermActive is manufactured by Hamilton Thorne Incorporated.
What is the FDA product code for GM501 SpermAir and GM501 SpermActive?
The FDA product code for GM501 SpermAir and GM501 SpermActive is MQL.
Other Devices by Hamilton Thorne Incorporated
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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.