Sensis

FDA 510(k) K150493 · Siemens Medi Cal Solutions, Inc.

Substantially Equivalent

510(k) numberK150493

Submission

Device name
Sensis
Applicant
Siemens Medi Cal Solutions, Inc.
Mavern, PA, US
Received
February 25, 2015
Decision date
June 30, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQK – Computer, Diagnostic, Programmable
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1425
Specialty
Cardiovascular

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Questions and answers

When was Sensis cleared by the FDA?

Sensis (K150493) received a 510(k) decision of Substantially Equivalent on June 30, 2015, 125 days after the submission was received.

What is the product code of K150493?

The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.