FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONTROL 282
K Number: K832066
·
Decision Sep 29, 1983
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
7
Applicant Total
1
Review Days
94
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Basic Information
- Device Name
- CONTROL 282
- K Number
- K832066
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3220
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Nustics, Inc.
- Date Received
- June 27, 1983
- Decision Date
- September 29, 1983
- 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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