Biochem 9090 CAPNOGRAPH/SAO2
by Biochem International, Inc.
510(k) K873856
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873856 | Date17 Dec 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CCK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1400
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Biochem 9090 Capnograph/Sao2 is a capnograph and Sao2 monitor. It is a device used in anesthesiology.
The device is supplied by Biochem International, Inc. and has FDA 510(k) clearance, with the clearance number K873856. It was cleared on December 17, 1987.
Other devices from Biochem International, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Biochem 9090 used for?
The Biochem 9090 is used in anesthesiology as a capnograph and Sao2 monitor, providing vital respiratory and oxygen saturation data.
Is the Biochem 9090 cleared by regulatory authorities?
Yes, the Biochem 9090 has FDA 510(k) clearance, with clearance number K873856, indicating it is substantially equivalent to a predicate device.
Who manufactures the Biochem 9090?
The Biochem 9090 is manufactured by Biochem International, Inc., based in Waukesha, Wisconsin, USA.