510(k) K801858
K801858 is an FDA 510(k) premarket notification submitted by Thoracel for the device "OXYMETER & TRANSOXODE". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code KLH (Antisera, C. Acnes), a Class I device regulated under 21 CFR 866.3140.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1980
- Date Received
- August 4, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, C. Acnes
- Device Class
- Class I
- Regulation Number
- 866.3140
- Review Panel
- MI
- Submission Type