FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPR PROMPT
K Number: K954692
·
Decision Mar 27, 1996
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
16
Applicant Total
1
Review Days
168
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Basic Information
- Device Name
- CPR PROMPT
- K Number
- K954692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- County Line , Ltd.
- Date Received
- October 11, 1995
- Decision Date
- March 27, 1996
- 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 |
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