510(k) K801858
- Device
- OXYMETER & TRANSOXODE
- Applicant
- Thoracel
- 510(k) number
- K801858
- Product code
- KLH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-13
- Date received
- 1980-08-04
- Regulation
- 866.3140
- Classification name
- Antisera, C. Acnes
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers
- 3023855650
Source Documents
510(k) summary PDF not indicated by FDA