FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AutoMark Module
K Number: K160218
·
Decision Dec 13, 2016
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
105
Review Days
319
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Basic Information
- Device Name
- AutoMark Module
- K Number
- K160218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- St Jude Medical
- Date Received
- January 29, 2016
- Decision Date
- December 13, 2016
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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