Respire Pink Series-Herbst-EF— 510(k) K150572
Substantially EquivalentRespire Medical Holding
FDA 510(k) clearance K150572 for Respire Pink Series-Herbst-EF, Substantially Equivalent on 2015-08-27. Applicant: Respire Medical Holding. Device class: 2.
Clearance details
- Applicant
- Respire Medical Holding
- 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
- Brooklyn, NY, US
Recent devices under product code LRK
view allMore clearances from Respire Medical Holding
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 →
Recalls naming K150572
K-number listed on FDA's recall record- Z-1947-2018 — Respire Pink Series EF+ Oral Sleep Apnea Device.
- Z-1948-2018 — Respire Pink+ Hard/Soft Oral Sleep Apnea Device
- Z-1949-2018 — Respire Pink+ Hard Oral Sleep Apnea Device
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150572.
Data sourced from openFDA. This site is unofficial and independent of the FDA.