THE BTE WS30— 510(k) K933611
Substantially EquivalentBaltimore Therapeutic Equipment Co.
FDA 510(k) clearance K933611 for THE BTE WS30, Substantially Equivalent on 1994-06-20. Applicant: Baltimore Therapeutic Equipment Co.. Device class: 2.
Clearance details
- Applicant
- Baltimore Therapeutic Equipment Co.
- Product code
- Code ISD
- Device class
- Class 2
- Regulation
- 21 CFR 890.5360
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hanover, MD, US
Recent devices under product code ISD
view allMore clearances from Baltimore Therapeutic Equipment Co.
view allAdverse 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 →
Recalls naming K933611
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 K933611.
Data sourced from openFDA. This site is unofficial and independent of the FDA.