Respire Pink AT (Hard, Hard/Soft, EF)— 510(k) K192127

Name: FDA 510(k) clearance K192127
Creator: U.S. Food and Drug Administration
Published: 2020-02-05

Substantially Equivalent

Respire 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. Device class: 2.

Clearance details

Applicant: Respire Medical Holdings
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2019-08-06
Decision date: 2020-02-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Brooklyn, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.