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)

ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE

K-Number: K837029 · 1983-03-22

ApplicantAmerican Electromedics Corp.
Decision Date1983-03-22
Product Code
DecisionSubstantially Equivalent

Device Summary

ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is American Electromedics Corp.. It received FDA 510(k) clearance on 1983-03-22 under 510(k) number K837029. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE?

ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE is a medical device that received FDA 510(k) clearance on 1983-03-22. The listed applicant is American Electromedics Corp.. The 510(k) number is K837029.

When did ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE receive FDA 510(k) clearance?

ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE received FDA 510(k) clearance on 1983-03-22, under 510(k) number K837029.

Who is the listed applicant for ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE?

The FDA 510(k) record lists American Electromedics Corp. as the applicant. This does not by itself establish the device manufacturer.

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 American Electromedics Corp. 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.

K983051AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTERK983049AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTERK983048AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTERK983046AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTERK972221K 15 AUDIOMETERK970279RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)

View all 20 devices →

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.

↑