FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITAFLOW SUCTION/ASPIRATION TUBING SET
K Number: K960616
·
Decision May 6, 1996
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
23
Applicant Total
4
Review Days
83
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Basic Information
- Device Name
- VITAFLOW SUCTION/ASPIRATION TUBING SET
- K Number
- K960616
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vital Concepts, Inc.
- Date Received
- February 13, 1996
- Decision Date
- May 6, 1996
- Product Code
- BYY
- 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 |
|---|---|---|---|
| BYY | Tube, Aspirating, Flexible, Connecting | FDA class 2 | General Hospital |
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