ACL TOP Family 70 Series
K-Number: K231031 · 2023-06-21
ApplicantInstrumentation Laboratory Company
Decision Date2023-06-21
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
ACL TOP Family 70 Series is a medical device manufactured by Instrumentation Laboratory Company. It received FDA 510(k) clearance on 2023-06-21 under approval number K231031. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ACL TOP Family 70 Series?
ACL TOP Family 70 Series is a medical device that received FDA 510(k) clearance on 2023-06-21. It is manufactured by Instrumentation Laboratory Company. The 510(k) number is K231031.
When was ACL TOP Family 70 Series approved by the FDA?
ACL TOP Family 70 Series received FDA 510(k) clearance on 2023-06-21, under approval number K231031.
What company makes ACL TOP Family 70 Series?
ACL TOP Family 70 Series is manufactured by Instrumentation Laboratory Company.
What is the FDA product code for ACL TOP Family 70 Series?
The FDA product code for ACL TOP Family 70 Series is GKP.
Other Devices by Instrumentation Laboratory Company
Related Devices (Code: GKP)
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.