ORAL AIRWAY— 510(k) K891586
Substantially EquivalentDynarex Corp.
FDA 510(k) clearance K891586 for ORAL AIRWAY, Substantially Equivalent on 1989-05-11. Applicant: Dynarex Corp.. Device class: 1.
Clearance details
- Applicant
- Dynarex Corp.
- 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
- Brewster, NY, US
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- K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA)
More clearances from Dynarex Corp.
view all- K052743 — DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
- K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
- K012816 — DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
- K012957 — TOWEL DRAPE, MODELS 4409, 4410
- K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
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.