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)

ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS

K-Number: K844120 · 1985-01-23

ApplicantEcho Ultrasound
Decision Date1985-01-23
Product CodeGXX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS is the device name listed in this FDA 510(k) record. The listed applicant is Echo Ultrasound. It received FDA 510(k) clearance on 1985-01-23 under 510(k) number K844120. The device is classified under product code GXX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS?

ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS is a medical device that received FDA 510(k) clearance on 1985-01-23. The listed applicant is Echo Ultrasound. The 510(k) number is K844120.

When did ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS receive FDA 510(k) clearance?

ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS received FDA 510(k) clearance on 1985-01-23, under 510(k) number K844120.

Who is the listed applicant for ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS?

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

What is the FDA product code for ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS?

The FDA product code for ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS is GXX.

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 Echo Ultrasound 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.

K924054PHONOCARDIOGRAPHK903414TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMNK893225COUPLANT WARMING DEVICEK872519STERILIZED OMNI GELK844034SONOCARE

Related Devices (Code: GXX)

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.

K893216RMI ULTRASOUND DOPPLER PHANTOM SYSTEMRadiation Measurements, Inc.K844247ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMSTechnicare Corp.

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.

↑