Hearing Healthcare Pro
K-Number: K183201 · 2019-03-06
ApplicantDb Diagnostic Systems, Inc.
Decision Date2019-03-06
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Hearing Healthcare Pro is a medical device manufactured by Db Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 2019-03-06 under approval number K183201. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Hearing Healthcare Pro?
Hearing Healthcare Pro is a medical device that received FDA 510(k) clearance on 2019-03-06. It is manufactured by Db Diagnostic Systems, Inc.. The 510(k) number is K183201.
When was Hearing Healthcare Pro approved by the FDA?
Hearing Healthcare Pro received FDA 510(k) clearance on 2019-03-06, under approval number K183201.
What company makes Hearing Healthcare Pro?
Hearing Healthcare Pro is manufactured by Db Diagnostic Systems, Inc..
What is the FDA product code for Hearing Healthcare Pro?
The FDA product code for Hearing Healthcare Pro is ETY.
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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.