FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ULTRA SOFTWARE MODULE: MODEL 2016
K Number: K863046
·
Decision Dec 5, 1986
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
24
Applicant Total
76
Review Days
115
Basic Information
- Device Name
- ULTRA SOFTWARE MODULE: MODEL 2016
- K Number
- K863046
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CARDIAC PACEMAKERS, INC.
- Date Received
- August 12, 1986
- Decision Date
- December 5, 1986
- Product Code
- KRG
- 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 |
|---|---|---|---|
| KRG | Programmer, Pacemaker | FDA class 3 | Cardiovascular |
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