FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGIPUMP
K Number: K935763
·
Decision Apr 21, 1994
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
8
Applicant Total
26
Review Days
146
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Basic Information
- Device Name
- SURGIPUMP
- K Number
- K935763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- W.O.M. World of Medicine GmbH
- Date Received
- November 26, 1993
- Decision Date
- April 21, 1994
- Product Code
- DQI
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQI | Withdrawal/Infusion Pump | FDA class 2 | Cardiovascular |
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