Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SentEP

K-Number: K192890 · 2020-09-18

ApplicantSentiar, Inc.
Decision Date2020-09-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SentEP is a medical device manufactured by Sentiar, Inc.. It received FDA 510(k) clearance on 2020-09-18 under approval number K192890. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SentEP?

SentEP is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by Sentiar, Inc.. The 510(k) number is K192890.

When was SentEP approved by the FDA?

SentEP received FDA 510(k) clearance on 2020-09-18, under approval number K192890.

What company makes SentEP?

SentEP is manufactured by Sentiar, Inc..

What is the FDA product code for SentEP?

The FDA product code for SentEP is LLZ.

Other Devices by Sentiar, Inc.

K223290CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑