OXYMETER & TRANSOXODE— 510(k) K801858
Substantially EquivalentThoracel
FDA 510(k) clearance K801858 for OXYMETER & TRANSOXODE, Substantially Equivalent on 1980-08-13. Applicant: Thoracel. Device class: 1.
Clearance details
- Applicant
- Thoracel
- Product code
- Code KLH
- Device class
- Class 1
- Regulation
- 21 CFR 866.3140
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.