DeviceClearance

CAPNOCHECK PLUS— 510(k) K970209

Substantially Equivalent

Bci Intl., Inc.

FDA 510(k) clearance K970209 for CAPNOCHECK PLUS, Substantially Equivalent on 1997-04-18. Applicant: Bci Intl., Inc.. Device class: 2.

Clearance details

Applicant
Bci Intl., 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
Download summary PDFView on FDA.gov ↗

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More clearances from Bci Intl., Inc.

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Adverse 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 K970209

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970209.

Data sourced from openFDA. This site is unofficial and independent of the FDA.