Sensis, Sensis Lite
FDA 510(k) K131812 · Siemens Medi Cal Solutions, Inc.
510(k) numberK131812
Submission
- Device name
- Sensis, Sensis Lite
- Applicant
- Siemens Medi Cal Solutions, Inc.
Mavern, PA, US - Received
- June 19, 2013
- Decision date
- July 25, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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, Sensis Lite cleared by the FDA?
Sensis, Sensis Lite (K131812) received a 510(k) decision of Substantially Equivalent on July 25, 2013, 36 days after the submission was received.
What is the product code of K131812?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.