HME-BOOSTER— 510(k) K990614
Substantially EquivalentKing Systems Corp.
FDA 510(k) clearance K990614 for HME-BOOSTER, Substantially Equivalent on 2000-05-23. Applicant: King Systems Corp.. Device class: 2.
Clearance details
- Applicant
- King Systems Corp.
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Noblesville, IN, US
Recent devices under product code BTT
view allMore clearances from King Systems Corp.
view all- K033189 — KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
- K033186 — KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
- K021634 — KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
- K012485 — MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE
- K010040 — SLEEVED FILTER
Adverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
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.