FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K Number: K901225
·
Decision Aug 23, 1990
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
34
Applicant Total
883
Review Days
162
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Basic Information
- Device Name
- LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
- K Number
- K901225
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- March 14, 1990
- Decision Date
- August 23, 1990
- Product Code
- KZD
- 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 |
|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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