FDA 510(k)

QUADRATENS, MODEL QT-42

K-Number: K061799 · 2006-08-28

Decision Date2006-08-28

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

QUADRATENS, MODEL QT-42 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Research Associates, Inc.. It received FDA 510(k) clearance on 2006-08-28 under 510(k) number K061799. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUADRATENS, MODEL QT-42?

QUADRATENS, MODEL QT-42 is a medical device that received FDA 510(k) clearance on 2006-08-28. The listed applicant is Bio-Research Associates, Inc.. The 510(k) number is K061799.

When did QUADRATENS, MODEL QT-42 receive FDA 510(k) clearance?

QUADRATENS, MODEL QT-42 received FDA 510(k) clearance on 2006-08-28, under 510(k) number K061799.

Who is the listed applicant for QUADRATENS, MODEL QT-42?

The FDA 510(k) record lists Bio-Research Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUADRATENS, MODEL QT-42?

The FDA product code for QUADRATENS, MODEL QT-42 is GZJ.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bio-Research Associates, Inc. as applicant

K130158M-SCAN K082927BIOEMG III K003176BIOEMG II AND BIOJVA K9917563 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE K981563BIOPAK MEASUREMENT SYSTEM K952218JT-3 ELECTROGNATHOGRAPH

View all 10 devices →

Related Devices (Code: GZJ)

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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.