SURGI TEK'S DISPOS. INNER CANNULA FOR— 510(k) K822295
Substantially EquivalentMedical Engineering Corp.
FDA 510(k) clearance K822295 for SURGI TEK'S DISPOS. INNER CANNULA FOR, Substantially Equivalent on 1982-08-20. Applicant: Medical Engineering Corp.. Device class: 2.
Clearance details
- Applicant
- Medical Engineering Corp.
- Product code
- Code BTO
- Device class
- Class 2
- Regulation
- 21 CFR 868.5800
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Medical Engineering Corp.
view allAdverse events under product code BTO
product code BTO- Death
- 14
- Injury
- 328
- Malfunction
- 1,851
- Total
- 2,193
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.