FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EZ PUMP
K Number: K926446
·
Decision Sep 27, 1993
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
47
Applicant Total
4
Review Days
278
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Basic Information
- Device Name
- EZ PUMP
- K Number
- K926446
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2720
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alphamed, Inc.
- Date Received
- December 23, 1992
- Decision Date
- September 27, 1993
- Product Code
- FRW
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRW | Scale, Patient | FDA class 1 | General Hospital |
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