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FDA 510(k)

DEVETHERM

K-Number: K822873 · 1983-03-24

ApplicantEko Scann AB
Decision Date1983-03-24
Product CodeDQB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEVETHERM is the device name listed in this FDA 510(k) record. The listed applicant is Eko Scann AB. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K822873. The device is classified under product code DQB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEVETHERM?

DEVETHERM is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Eko Scann AB. The 510(k) number is K822873.

When did DEVETHERM receive FDA 510(k) clearance?

DEVETHERM received FDA 510(k) clearance on 1983-03-24, under 510(k) number K822873.

Who is the listed applicant for DEVETHERM?

The FDA 510(k) record lists Eko Scann AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEVETHERM?

The FDA product code for DEVETHERM is DQB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Eko Scann AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K822823HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT

Related Devices (Code: DQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K851102VASOSCREEN IMPEDANCE PLETHYSMOGRAPHSonicaid, Inc.K772093IMPEDANCE RHEOGRAPHDynatech Research & Development Co.

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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