FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPR HELPER
K Number: K801946
·
Decision Nov 19, 1980
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
44
Applicant Total
3
Review Days
97
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Basic Information
- Device Name
- CPR HELPER
- K Number
- K801946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cardia Concepts Corp.
- Date Received
- August 14, 1980
- Decision Date
- November 19, 1980
- Product Code
- DRM
- 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 |
|---|---|---|---|
| DRM | Compressor, Cardiac, External | FDA class 2 | Cardiovascular |
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