Respire Pink AT (Hard, Hard/Soft, EF)— 510(k) K192127
Substantially EquivalentRespire Medical Holdings
FDA 510(k) clearance K192127 for Respire Pink AT (Hard, Hard/Soft, EF), Substantially Equivalent on 2020-02-05. Applicant: Respire Medical Holdings.
Clearance details
- Applicant
- Respire Medical Holdings
- Product code
- Code LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Brooklyn, NY, US
Adverse 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.