FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSM3 HEMOXIMETER
K Number: K853990
·
Decision Dec 30, 1985
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
7
Applicant Total
49
Review Days
94
Basic Information
- Device Name
- OSM3 HEMOXIMETER
- K Number
- K853990
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3220
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- RADIOMETER AMERICA, INC.
- Date Received
- September 27, 1985
- Decision Date
- December 30, 1985
- 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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