OSM3 HEMOXIMETER— 510(k) K853990
Substantially EquivalentRadiometer America, Inc.
FDA 510(k) clearance K853990 for OSM3 HEMOXIMETER, Substantially Equivalent on 1985-12-30. Applicant: Radiometer America, Inc.. Device class: 1.
Clearance details
- Applicant
- Radiometer America, Inc.
- Product code
- Code JKS
- Device class
- Class 1
- Regulation
- 21 CFR 862.3220
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.