THE LUOMANEN ORAL AIRWAY— 510(k) K810123
Substantially EquivalentLuomanen Medical Products
FDA 510(k) clearance K810123 for THE LUOMANEN ORAL AIRWAY, Substantially Equivalent on 1981-02-26. Applicant: Luomanen Medical Products. Device class: 1.
Clearance details
- Applicant
- Luomanen Medical Products
- Product code
- Code CAE
- Device class
- Class 1
- Regulation
- 21 CFR 868.5110
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CAE
view all- K130304 — LMA FAMILY OF AIRWAYS
- 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
- K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA)
Adverse events under product code CAE
product code CAE- Death
- 4
- Total
- 4
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.