ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS— 510(k) K844120

Name: FDA 510(k) clearance K844120
Creator: U.S. Food and Drug Administration
Published: 1985-01-23

Substantially Equivalent

Echo Ultrasound

FDA 510(k) clearance K844120 for ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS, Substantially Equivalent on 1985-01-23. Applicant: Echo Ultrasound. Device class: 1.

Clearance details

Applicant: Echo Ultrasound
Product code: Code GXX
Device class: Class 1
Regulation: 21 CFR 882.1925
Advisory panel: Neurology
Date received: 1984-10-23
Decision date: 1985-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewistown, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXX

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K893216 — RMI ULTRASOUND DOPPLER PHANTOM SYSTEM1989-09-05
K844247 — ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS1985-01-23

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K924054 — PHONOCARDIOGRAPH1993-01-22
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K893225 — COUPLANT WARMING DEVICE1989-10-12
K872519 — STERILIZED OMNI GEL1987-08-03
K844034 — SONOCARE1985-01-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.