Ultrasonic Scanner Calibration & Test Objects

FDA 510(k) K844120 · Echo Ultrasound

Substantially Equivalent

510(k) numberK844120

Submission

Device name
Ultrasonic Scanner Calibration & Test Objects
Applicant
Echo Ultrasound
Lewistown, PA, US
Received
October 23, 1984
Decision date
January 23, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GXX – Block, Test, Ultrasonic Scanner Calibration
Device class
Class I (low risk)
Regulation
21 CFR 882.1925
Specialty
Neurology

Other 510(k)s with product code GXX

510(k)DeviceApplicantDecision
K893216Rmi Ultrasound Doppler Phantom SystemGXX · Traditional Radiation Measurements, Inc.09/05/1989SE
K844247Ultrasonic Scanner Calibration & Test PhantomsGXX · Traditional Technicare Corp.01/23/1985SE

More from Technicare Corp.

510(k)DeviceDecision
K924054PhonocardiographDQC · Traditional 01/22/1993SE
K903414Transesophageal Probe Holder & Disinfecting ColumnDXK · Traditional 09/19/1990SE
K893225Couplant Warming DeviceIYO · Traditional 10/12/1989SE
K872519Sterilized Omni GelJOT · Traditional 08/03/1987SE
K844034SonocareDYO · Traditional 01/23/1985SE

Questions and answers

When was Ultrasonic Scanner Calibration & Test Objects cleared by the FDA?

Ultrasonic Scanner Calibration & Test Objects (K844120) received a 510(k) decision of Substantially Equivalent on January 23, 1985, 92 days after the submission was received.

What is the product code of K844120?

The FDA product code is GXX – Block, Test, Ultrasonic Scanner Calibration, a Class I (low risk) device regulated under 21 CFR 882.1925.