DELTAWAVE Nasal Pillows System— 510(k) K233415

Substantially Equivalent

Remsleep Holdings

FDA 510(k) clearance K233415 for DELTAWAVE Nasal Pillows System, Substantially Equivalent on 2024-07-02. Applicant: Remsleep Holdings.

Clearance details

Applicant: Remsleep Holdings
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2023-10-10
Decision date: 2024-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.