EmBody System
K-Number: K183450 · 2019-06-20
ApplicantInmode MD , Ltd.
Decision Date2019-06-20
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
EmBody System is a medical device manufactured by Inmode MD , Ltd.. It received FDA 510(k) clearance on 2019-06-20 under approval number K183450. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EmBody System?
EmBody System is a medical device that received FDA 510(k) clearance on 2019-06-20. It is manufactured by Inmode MD , Ltd.. The 510(k) number is K183450.
When was EmBody System approved by the FDA?
EmBody System received FDA 510(k) clearance on 2019-06-20, under approval number K183450.
What company makes EmBody System?
EmBody System is manufactured by Inmode MD , Ltd..
What is the FDA product code for EmBody System?
The FDA product code for EmBody System is PBX.
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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.