FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
LITHIUM PACEMAKER 811-811L & 811XL
K Number: K840748
·
Decision Aug 3, 1984
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
4
Review Days
162
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Basic Information
- Device Name
- LITHIUM PACEMAKER 811-811L & 811XL
- K Number
- K840748
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Omikron Scientific, Ltd.
- Date Received
- February 23, 1984
- Decision Date
- August 3, 1984
- 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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