FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPR PLUS
K Number: K926333
·
Decision Nov 8, 1993
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
16
Applicant Total
12
Review Days
327
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Basic Information
- Device Name
- CPR PLUS
- K Number
- K926333
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kells Medical, Inc.
- Date Received
- December 16, 1992
- Decision Date
- November 8, 1993
- Product Code
- LIX
- 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 |
|---|---|---|---|
| LIX | Aid, Cardiopulmonary Resuscitation | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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