FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 5311B A-V PACING SYSTEM ANALYZER
K Number: K910595
·
Decision May 7, 1991
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
29
Applicant Total
475
Review Days
84
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Basic Information
- Device Name
- MODEL 5311B A-V PACING SYSTEM ANALYZER
- K Number
- K910595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3630
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medtronic Vascular
- Date Received
- February 12, 1991
- Decision Date
- May 7, 1991
- Product Code
- DTC
- 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 |
|---|---|---|---|
| DTC | Analyzer, Pacemaker Generator Function | FDA class 2 | Cardiovascular |
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