FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Medtronic Temporary External Pacemaker 53401
K Number: K162054
·
Decision Oct 18, 2016
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
209
Review Days
85
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Basic Information
- Device Name
- Medtronic Temporary External Pacemaker 53401
- K Number
- K162054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- July 25, 2016
- Decision Date
- October 18, 2016
- Product Code
- DTE
- 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 |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | FDA class 2 | Cardiovascular |
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