FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD
K Number: K935371
·
Decision Dec 2, 1994
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
1
Review Days
389
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Basic Information
- Device Name
- R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD
- K Number
- K935371
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- R2 Medical Systems
- Date Received
- November 8, 1993
- Decision Date
- December 2, 1994
- Product Code
- DRX
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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