Sentry WEB SmartInterp
FDA 510(k) K153654 · Carefusion Germany 234 GmbH
510(k) numberK153654
Submission
- Device name
- Sentry WEB SmartInterp
- Applicant
- Carefusion Germany 234 GmbH
Hoechber, DE - Received
- December 21, 2015
- Decision date
- September 16, 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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| K122699 | Sentrysuite Product LineBTY · Traditional | 11/19/2012SE |
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| K113096 | Micro IBZG · Traditional | 04/13/2012SE |
| K111408 | Microgard IICAH · Traditional | 10/17/2011SE |
| K111053 | Sentrysuite Product LineBTY · Traditional | 08/12/2011SE |
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Questions and answers
When was Sentry WEB SmartInterp cleared by the FDA?
Sentry WEB SmartInterp (K153654) received a 510(k) decision of Substantially Equivalent on September 16, 2016, 270 days after the submission was received.
What is the product code of K153654?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.