FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
OneStim-DUO Cardiac Stimulator (MP5003-4CO)
K Number: K253088
·
Decision Jun 12, 2026
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
3
Review Days
262
Basic Information
- Device Name
- OneStim-DUO Cardiac Stimulator (MP5003-4CO)
- K Number
- K253088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micropace Pty, Ltd.
- Date Received
- September 23, 2025
- Decision Date
- June 12, 2026
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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