FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICU STOPCOK WITH EXTENSION TUBING
K Number: K953573
·
Decision Oct 7, 1995
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
66
Review Days
68
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Basic Information
- Device Name
- ICU STOPCOK WITH EXTENSION TUBING
- K Number
- K953573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icu Medical, Inc.
- Date Received
- July 31, 1995
- Decision Date
- October 7, 1995
- 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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