FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K Number: K842364
·
Decision Sep 24, 1984
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
24
Applicant Total
76
Review Days
98
Basic Information
- Device Name
- HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
- K Number
- K842364
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CARDIAC PACEMAKERS, INC.
- Date Received
- June 18, 1984
- Decision Date
- September 24, 1984
- 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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