BodyTom 64
K-Number: K213649 · 2022-04-29
ApplicantNeurologica Corporation
Decision Date2022-04-29
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BodyTom 64 is a medical device manufactured by Neurologica Corporation. It received FDA 510(k) clearance on 2022-04-29 under approval number K213649. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BodyTom 64?
BodyTom 64 is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Neurologica Corporation. The 510(k) number is K213649.
When was BodyTom 64 approved by the FDA?
BodyTom 64 received FDA 510(k) clearance on 2022-04-29, under approval number K213649.
What company makes BodyTom 64?
BodyTom 64 is manufactured by Neurologica Corporation.
What is the FDA product code for BodyTom 64?
The FDA product code for BodyTom 64 is JAK.
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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.