FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
CHANGE TO CATHODE POWDER SPECIFICATION
K Number: K881904
·
Decision Jul 22, 1988
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
3
Review Days
77
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Basic Information
- Device Name
- CHANGE TO CATHODE POWDER SPECIFICATION
- K Number
- K881904
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Telectronics and Cordis Pacing Systems
- Date Received
- May 6, 1988
- Decision Date
- July 22, 1988
- 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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