airVata— 510(k) K240427
Substantially EquivalentGelb Practice Solutions, Inc.
FDA 510(k) clearance K240427 for airVata, Substantially Equivalent on 2024-02-14. Applicant: Gelb Practice Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Gelb Practice Solutions, Inc.
- Product code
- Code LRK
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dix Hills, NY, US
Recent devices under product code LRK
view allAdverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
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.