PAPILLON MASK SET— 510(k) K023068

Name: FDA 510(k) clearance K023068
Creator: U.S. Food and Drug Administration
Published: 2003-05-28

Substantially Equivalent

Map Medizintechnik Fur Arzt Und Patient GmbH

FDA 510(k) clearance K023068 for PAPILLON MASK SET, Substantially Equivalent on 2003-05-28. Applicant: Map Medizintechnik Fur Arzt Und Patient GmbH. Device class: 2.

Clearance details

Applicant: Map Medizintechnik Fur Arzt Und Patient GmbH
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2002-09-16
Decision date: 2003-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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K254104 — ResScan Essentials2026-05-27
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K253166 — F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)2026-04-29

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K040576 — MICROMESAM BASIC-SET2004-07-01
K993094 — AERO-CLICK2000-10-23

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.