BTL-99-OC
K-Number: K230657 · 2024-02-01
ApplicantBTL Industries, Inc.
Decision Date2024-02-01
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BTL-99-OC is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2024-02-01 under approval number K230657. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BTL-99-OC?
BTL-99-OC is a medical device that received FDA 510(k) clearance on 2024-02-01. It is manufactured by BTL Industries, Inc.. The 510(k) number is K230657.
When was BTL-99-OC approved by the FDA?
BTL-99-OC received FDA 510(k) clearance on 2024-02-01, under approval number K230657.
What company makes BTL-99-OC?
BTL-99-OC is manufactured by BTL Industries, Inc..
What is the FDA product code for BTL-99-OC?
The FDA product code for BTL-99-OC is QCI.
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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.