BIOCHEM 8090 CAPNOGRAPH— 510(k) K871133
Substantially EquivalentBiochem International, Inc.
FDA 510(k) clearance K871133 for BIOCHEM 8090 CAPNOGRAPH, Substantially Equivalent on 1987-04-21. Applicant: Biochem International, Inc.. Device class: 2.
Clearance details
- Applicant
- Biochem International, Inc.
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code CCK
view allMore clearances from Biochem International, Inc.
view allAdverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K871133
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K871133.
Data sourced from openFDA. This site is unofficial and independent of the FDA.