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

FDA 510(k)

SOUNDTEK MODEL UT-4700

K-Number: K864766 · 1987-03-12

ApplicantSoundtek, Inc.
Decision Date1987-03-12
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOUNDTEK MODEL UT-4700 is the device name listed in this FDA 510(k) record. The listed applicant is Soundtek, Inc.. It received FDA 510(k) clearance on 1987-03-12 under 510(k) number K864766. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOUNDTEK MODEL UT-4700?

SOUNDTEK MODEL UT-4700 is a medical device that received FDA 510(k) clearance on 1987-03-12. The listed applicant is Soundtek, Inc.. The 510(k) number is K864766.

When did SOUNDTEK MODEL UT-4700 receive FDA 510(k) clearance?

SOUNDTEK MODEL UT-4700 received FDA 510(k) clearance on 1987-03-12, under 510(k) number K864766.

Who is the listed applicant for SOUNDTEK MODEL UT-4700?

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

What is the FDA product code for SOUNDTEK MODEL UT-4700?

The FDA product code for SOUNDTEK MODEL UT-4700 is IMJ.

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

Related Devices (Code: IMJ)

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.

K252963BTL-899TTBTL Industries, Inc.K250376ViVYViatherm Therapeutics, LLCK243112Curapuls 670Enraf-Nonius, B.V.K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.K182363BTL-703BTL Industries, Inc.K173300ViaTherm BOOSTViatherm Therapeutics, 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.

↑