FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
EPS320 CARDIAC STIMULATOR
K Number: K011826
·
Decision Jan 24, 2002
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
17
Applicant Total
3
Review Days
227
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Basic Information
- Device Name
- EPS320 CARDIAC STIMULATOR
- K Number
- K011826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1750
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micropace Pty, Ltd.
- Date Received
- June 11, 2001
- Decision Date
- January 24, 2002
- Product Code
- JOQ
- 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 |
|---|---|---|---|
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | FDA class 2 | Cardiovascular |
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