FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
DURAPULSE
K Number: K823371
·
Decision Dec 22, 1982
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
1
Review Days
40
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Basic Information
- Device Name
- DURAPULSE
- K Number
- K823371
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cpm International, Inc.
- Date Received
- November 12, 1982
- Decision Date
- December 22, 1982
- Product Code
- DXY
- 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
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