FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K Number: K910237
·
Decision Feb 25, 1991
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
475
Review Days
38
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Basic Information
- Device Name
- MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
- K Number
- K910237
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medtronic Vascular
- Date Received
- January 18, 1991
- Decision Date
- February 25, 1991
- Product Code
- DTE
- 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 |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | FDA class 2 | Cardiovascular |
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