FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
BLOOD GAS EXPERSYSTEM 8700
K Number: K833430
·
Decision Feb 10, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
1
Review Days
128
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Basic Information
- Device Name
- BLOOD GAS EXPERSYSTEM 8700
- K Number
- K833430
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Medical Intelcom, Inc.
- Date Received
- October 5, 1983
- Decision Date
- February 10, 1984
- Product Code
- LLE
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| LLE | Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease | FDA class 3 | Unknown |
Similar 510(k) Clearances
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