FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOMED
K Number: K103651
·
Decision Oct 4, 2011
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
3
Review Days
294
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Basic Information
- Device Name
- CARDIOMED
- K Number
- K103651
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardio Medical Products, Inc.
- Date Received
- December 14, 2010
- Decision Date
- October 4, 2011
- Product Code
- LDD
- 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | FDA class 2 | Cardiovascular |
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