CRITIKON OXYGEN MONITOR, MODEL 8030— 510(k) K821936
Substantially EquivalentCritikon Company, LLC
FDA 510(k) clearance K821936 for CRITIKON OXYGEN MONITOR, MODEL 8030, Substantially Equivalent on 1982-08-16. Applicant: Critikon Company, LLC. Device class: 2.
Clearance details
- Applicant
- Critikon Company, LLC
- Product code
- Code KLK
- Device class
- Class 2
- Regulation
- 21 CFR 868.2500
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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