510(k) K893877
K893877 is an FDA 510(k) premarket notification submitted by Biochem International, Inc. for the device "BIOCHEM 3100 OXIMETER". The FDA issued a decision of Substantially Equivalent on December 20, 1989. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Biochem International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 1989
- Date Received
- May 26, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type