FISIO CHAMBER SPACE— 510(k) K101136
Substantially EquivalentKoo (Shanghai) Industries Co., Ltd.
FDA 510(k) clearance K101136 for FISIO CHAMBER SPACE, Substantially Equivalent on 2011-01-28. Applicant: Koo (Shanghai) Industries Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Koo (Shanghai) Industries Co., Ltd.
- Product code
- Code NVP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
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More clearances from Koo (Shanghai) Industries Co., Ltd.
view allAdverse events under product code NVP
product code NVP- Other
- 1
- Total
- 1
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.