OXYMETER & TRANSOXODE
FDA 510(k) clearance K801858 · decided 1980-08-13
Clearance details
- K-number
- K801858
- Device name
- OXYMETER & TRANSOXODE
- Applicant
- Thoracel
- Decision
- Substantially Equivalent
- Date received
- 1980-08-04
- Decision date
- 1980-08-13
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- KLH
- Device class
- 1
- Regulation number
- 866.3140
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.