iBed Wireless with iBed Mobile— 510(k) K202964
Substantially EquivalentStryker Corporation
FDA 510(k) clearance K202964 for iBed Wireless with iBed Mobile, Substantially Equivalent on 2021-06-18. Applicant: Stryker Corporation. Device class: 2.
Clearance details
- Applicant
- Stryker Corporation
- Product code
- Code FNL
- Device class
- Class 2
- Regulation
- 21 CFR 880.5100
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
Recent devices under product code FNL
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Adverse events under product code FNL
product code FNL- Death
- 64
- Injury
- 728
- Malfunction
- 10,825
- Other
- 9
- Total
- 11,626
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.