Transcran(Tm) Transcranial Pulsed Doppler System

FDA 510(k) K882015 · Ultramed, Inc.

Substantially Equivalent

510(k) numberK882015

Submission

Device name
Transcran(Tm) Transcranial Pulsed Doppler System
Applicant
Ultramed, Inc.
North Brunswick, NJ, US
Received
May 13, 1988
Decision date
September 8, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IYN – System, Imaging, Pulsed Doppler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1550
Specialty
Radiology

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More from Beijing Konted Medical Technology Co.,Ltd

510(k)DeviceDecision
K873989Dopplex Ultrasonic Doppler SystemJOP · Traditional 03/02/1988SE
K861378Ultramed TF 122 Ultrason Vascu Imag & Doppler SystJOP · Traditional 07/07/1986SE
K862021Phacoemulsification Ultrasonic Fragment SystemHQC · Traditional 06/23/1986SE
K850578Phacoemulsification TipHQC · Traditional 04/03/1985SE

Questions and answers

When was Transcran(Tm) Transcranial Pulsed Doppler System cleared by the FDA?

Transcran(Tm) Transcranial Pulsed Doppler System (K882015) received a 510(k) decision of Substantially Equivalent on September 8, 1988, 118 days after the submission was received.

What is the product code of K882015?

The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.