BREATHING CIRCUIT BACTERIAL FILTER— 510(k) K973797
Substantially EquivalentKing Systems Corp.
FDA 510(k) clearance K973797 for BREATHING CIRCUIT BACTERIAL FILTER, Substantially Equivalent on 1998-03-12. Applicant: King Systems Corp.. Device class: 2.
Clearance details
- Applicant
- King Systems Corp.
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Noblesville, IN, US
Recent devices under product code CAH
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 CAH
product code CAH- 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 →
Recalls naming K973797
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 K973797.
Data sourced from openFDA. This site is unofficial and independent of the FDA.