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FDA 510(k)

Sensus Healthcare TVM Balloon Applicator

K-Number: K190255 · 2019-02-21

ApplicantSensus Healthcare, Inc.
Decision Date2019-02-21
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sensus Healthcare TVM Balloon Applicator is a medical device manufactured by Sensus Healthcare, Inc.. It received FDA 510(k) clearance on 2019-02-21 under approval number K190255. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sensus Healthcare TVM Balloon Applicator?

Sensus Healthcare TVM Balloon Applicator is a medical device that received FDA 510(k) clearance on 2019-02-21. It is manufactured by Sensus Healthcare, Inc.. The 510(k) number is K190255.

When was Sensus Healthcare TVM Balloon Applicator approved by the FDA?

Sensus Healthcare TVM Balloon Applicator received FDA 510(k) clearance on 2019-02-21, under approval number K190255.

What company makes Sensus Healthcare TVM Balloon Applicator?

Sensus Healthcare TVM Balloon Applicator is manufactured by Sensus Healthcare, Inc..

What is the FDA product code for Sensus Healthcare TVM Balloon Applicator?

The FDA product code for Sensus Healthcare TVM Balloon Applicator is JAD.

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Other Devices by Sensus Healthcare, Inc.

K173425SRT-100+ K182665Sensus TPS Workstation K182641Sensus IORT System

Related Devices (Code: JAD)

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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.

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