WiZARD 510 Nasal Mask— 510(k) K193206

Name: FDA 510(k) clearance K193206
Creator: U.S. Food and Drug Administration
Published: 2020-10-29

Substantially Equivalent

Apex Medical Corp.

FDA 510(k) clearance K193206 for WiZARD 510 Nasal Mask, Substantially Equivalent on 2020-10-29. Applicant: Apex Medical Corp.. Device class: 2.

Clearance details

Applicant: Apex Medical Corp.
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2019-11-20
Decision date: 2020-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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K253166 — F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)2026-04-29

More clearances from Apex Medical Corp.

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K213577 — VenAir, Sequential Compression System2022-06-28
K182394 — WiZARD 310/320 Series CPAP Mask2019-05-17
K150111 — Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series2015-09-15
K141522 — APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES2014-10-06
K121642 — WIZARD 230 NASAL PILOW MASK2013-06-06

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.