THE BTE WS30— 510(k) K933611

Substantially Equivalent

Baltimore Therapeutic Equipment Co.

FDA 510(k) clearance K933611 for THE BTE WS30, Substantially Equivalent on 1994-06-20. Applicant: Baltimore Therapeutic Equipment Co..

Clearance details

Applicant
Baltimore Therapeutic Equipment Co.
Product code
Code ISD
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hanover, MD, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ISD

product code ISD
Other
2
Total
2

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.