FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOPULSE, MODEL 100
K Number: K011046
·
Decision Oct 25, 2001
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
44
Applicant Total
4
Review Days
202
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Basic Information
- Device Name
- AUTOPULSE, MODEL 100
- K Number
- K011046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Revivant Corp.
- Date Received
- April 6, 2001
- Decision Date
- October 25, 2001
- 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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