Innova Nasal Non-Vented Mask— 510(k) K203601

Substantially Equivalent

Sleepnet Corporation

FDA 510(k) clearance K203601 for Innova Nasal Non-Vented Mask, Substantially Equivalent on 2021-04-30. Applicant: Sleepnet Corporation.

Clearance details

Applicant: Sleepnet Corporation
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2020-12-09
Decision date: 2021-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampton, NH, 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.