FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IL 482 CO-OXIMETER
K Number: K862253
·
Decision Jul 29, 1986
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
7
Applicant Total
321
Review Days
46
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Basic Information
- Device Name
- IL 482 CO-OXIMETER
- K Number
- K862253
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3220
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Instrumentation Laboratory CO
- Date Received
- June 13, 1986
- Decision Date
- July 29, 1986
- Product Code
- JKS
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| JKS | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | FDA class 1 | Clinical Toxicology |
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