WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)— 510(k) K001997
Substantially EquivalentWhite Knight Healthcare, Inc.
FDA 510(k) clearance K001997 for WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS), Substantially Equivalent on 2001-04-02. Applicant: White Knight Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- White Knight Healthcare, Inc.
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Port Riche, FL, US
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More clearances from White Knight Healthcare, Inc.
view allAdverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
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.