FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABC IN-LINE BLOOD SAMPLING KIT
K Number: K955663
·
Decision Mar 17, 1997
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
38
Review Days
460
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Basic Information
- Device Name
- ABC IN-LINE BLOOD SAMPLING KIT
- K Number
- K955663
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Utah Medical Products, Inc.
- Date Received
- December 13, 1995
- Decision Date
- March 17, 1997
- Product Code
- CBT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBT | Arterial Blood Sampling Kit | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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