Sono TT Ultrasonic Flowcomputer

FDA 510(k) K040909 · Em-Tec GmbH

Substantially Equivalent

510(k) numberK040909

Submission

Device name
Sono TT Ultrasonic Flowcomputer
Applicant
Em-Tec GmbH
Finning, Bavaria, DE
Received
April 8, 2004
Decision date
April 20, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

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Questions and answers

When was Sono TT Ultrasonic Flowcomputer cleared by the FDA?

Sono TT Ultrasonic Flowcomputer (K040909) received a 510(k) decision of Substantially Equivalent on April 20, 2004, 12 days after the submission was received.

What is the product code of K040909?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.