FLEX BLUE— 510(k) K950318
Substantially EquivalentKing Systems Corp.
FDA 510(k) clearance K950318 for FLEX BLUE, Substantially Equivalent on 1995-02-13. Applicant: King Systems Corp.. Device class: 1.
Clearance details
- Applicant
- King Systems Corp.
- Product code
- Code CBH
- Device class
- Class 1
- Regulation
- 21 CFR 868.5770
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Noblesville, IN, US
Recent devices under product code CBH
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- 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 CBH
product code CBH- Death
- 7
- Total
- 7
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.