Sentinel Cardiology Information Management System
FDA 510(k) K152881 · Spacelabs Healthcare, Ltd.
510(k) numberK152881
Submission
- Device name
- Sentinel Cardiology Information Management System
- Applicant
- Spacelabs Healthcare, Ltd.
Hertford, GB - Received
- September 30, 2015
- Decision date
- April 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Sentinel Cardiology Information Management System cleared by the FDA?
Sentinel Cardiology Information Management System (K152881) received a 510(k) decision of Substantially Equivalent on April 1, 2016, 184 days after the submission was received.
What is the product code of K152881?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.