FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
K Number: K896514
·
Decision Jan 23, 1990
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
38
Applicant Total
49
Review Days
70
Basic Information
- Device Name
- QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
- K Number
- K896514
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- RADIOMETER AMERICA, INC.
- Date Received
- November 14, 1989
- Decision Date
- January 23, 1990
- Product Code
- GIM
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | FDA class 2 | Clinical Chemistry |
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