Safey Pocket Spirometer
K-Number: K201002 · 2020-07-30
ApplicantSafey Medical Devices Pvt, Ltd.
Decision Date2020-07-30
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Safey Pocket Spirometer is a medical device manufactured by Safey Medical Devices Pvt, Ltd.. It received FDA 510(k) clearance on 2020-07-30 under approval number K201002. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Safey Pocket Spirometer?
Safey Pocket Spirometer is a medical device that received FDA 510(k) clearance on 2020-07-30. It is manufactured by Safey Medical Devices Pvt, Ltd.. The 510(k) number is K201002.
When was Safey Pocket Spirometer approved by the FDA?
Safey Pocket Spirometer received FDA 510(k) clearance on 2020-07-30, under approval number K201002.
What company makes Safey Pocket Spirometer?
Safey Pocket Spirometer is manufactured by Safey Medical Devices Pvt, Ltd..
What is the FDA product code for Safey Pocket Spirometer?
The FDA product code for Safey Pocket Spirometer is BZG.
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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.