FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MOSQUITO ARTERIAL BLOOD SAMPLER
K Number: K791465
·
Decision Sep 17, 1979
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
4
Review Days
48
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Basic Information
- Device Name
- MOSQUITO ARTERIAL BLOOD SAMPLER
- K Number
- K791465
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Emde Corp.
- Date Received
- July 31, 1979
- Decision Date
- September 17, 1979
- 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 |
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