Human Tecar HCR 1002
K-Number: K181211 · 2018-09-10
ApplicantUnibell S.R.L
Decision Date2018-09-10
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Human Tecar HCR 1002 is a medical device manufactured by Unibell S.R.L. It received FDA 510(k) clearance on 2018-09-10 under approval number K181211. 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 Human Tecar HCR 1002?
Human Tecar HCR 1002 is a medical device that received FDA 510(k) clearance on 2018-09-10. It is manufactured by Unibell S.R.L. The 510(k) number is K181211.
When was Human Tecar HCR 1002 approved by the FDA?
Human Tecar HCR 1002 received FDA 510(k) clearance on 2018-09-10, under approval number K181211.
What company makes Human Tecar HCR 1002?
Human Tecar HCR 1002 is manufactured by Unibell S.R.L.
What is the FDA product code for Human Tecar HCR 1002?
The FDA product code for Human Tecar HCR 1002 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.