PROTECTIVE RESTRAINT— 510(k) K110377
Substantially EquivalentMedi-Tech Intl. Corp.
FDA 510(k) clearance K110377 for PROTECTIVE RESTRAINT, Substantially Equivalent on 2011-04-25. Applicant: Medi-Tech Intl. Corp.. Device class: 1.
Clearance details
- Applicant
- Medi-Tech Intl. Corp.
- Product code
- Code FMQ
- Device class
- Class 1
- Regulation
- 21 CFR 880.6760
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brooklyn, NY, US
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More clearances from Medi-Tech Intl. Corp.
view allAdverse events under product code FMQ
product code FMQ- Death
- 8
- Total
- 8
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.