AutoMark Module
FDA 510(k) K160218 · St Jude Medical
510(k) numberK160218
Submission
- Device name
- AutoMark Module
- Applicant
- St Jude Medical
St. Paul, MN, US - Received
- January 29, 2016
- Decision date
- December 13, 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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| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…DRF · Traditional | 12/13/2016SE |
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Questions and answers
When was AutoMark Module cleared by the FDA?
AutoMark Module (K160218) received a 510(k) decision of Substantially Equivalent on December 13, 2016, 319 days after the submission was received.
What is the product code of K160218?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.