Sonott Flowlab(R)

FDA 510(k) K111730 · Em-Tec GmbH

Substantially Equivalent

510(k) numberK111730

Submission

Device name
Sonott Flowlab(R)
Applicant
Em-Tec GmbH
Finning, Bavaria, DE
Received
June 20, 2011
Decision date
January 6, 2012
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary 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 Sonott Flowlab(R) cleared by the FDA?

Sonott Flowlab(R) (K111730) received a 510(k) decision of Substantially Equivalent on January 6, 2012, 200 days after the submission was received.

What is the product code of K111730?

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