FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
K Number: K974083
·
Decision Jan 13, 1998
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
120
Review Days
76
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Basic Information
- Device Name
- CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
- K Number
- K974083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ohmeda Medical
- Date Received
- October 29, 1997
- Decision Date
- January 13, 1998
- Product Code
- FMG
- 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 |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | FDA class 2 | General Hospital |
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