BZF-29
K-Number: K200682 · 2020-10-02
ApplicantGC America, Inc.
Decision Date2020-10-02
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BZF-29 is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2020-10-02 under approval number K200682. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BZF-29?
BZF-29 is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by GC America, Inc.. The 510(k) number is K200682.
When was BZF-29 approved by the FDA?
BZF-29 received FDA 510(k) clearance on 2020-10-02, under approval number K200682.
What company makes BZF-29?
BZF-29 is manufactured by GC America, Inc..
What is the FDA product code for BZF-29?
The FDA product code for BZF-29 is KLE.
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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.