DeviceClearance

MODEL SIX BEAM SYSTEM— 510(k) K811848

Substantially Equivalent

Braintech, Inc.

FDA 510(k) clearance K811848 for MODEL SIX BEAM SYSTEM, Substantially Equivalent on 1981-09-08. Applicant: Braintech, Inc.. Device class: 2.

Clearance details

Applicant
Braintech, Inc.
Product code
Code GWF
Device class
Class 2
Regulation
21 CFR 882.1870
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GWF

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Adverse events under product code GWF

product code GWF
Malfunction
2,364
Other
4
Total
2,368

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 →

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