RespiraSense
K-Number: K220111 · 2022-10-07
ApplicantPmd Solutions
Decision Date2022-10-07
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
RespiraSense is a medical device manufactured by Pmd Solutions. It received FDA 510(k) clearance on 2022-10-07 under approval number K220111. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RespiraSense?
RespiraSense is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by Pmd Solutions. The 510(k) number is K220111.
When was RespiraSense approved by the FDA?
RespiraSense received FDA 510(k) clearance on 2022-10-07, under approval number K220111.
What company makes RespiraSense?
RespiraSense is manufactured by Pmd Solutions.
What is the FDA product code for RespiraSense?
The FDA product code for RespiraSense is BZQ.
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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.