DeviceClearance

Panoramic Oxygen Mask (POM)— 510(k) K172365

Substantially Equivalent

Pom Medical, LLC

FDA 510(k) clearance K172365 for Panoramic Oxygen Mask (POM), Substantially Equivalent on 2018-04-19. Applicant: Pom Medical, LLC. Device class: 2.

Clearance details

Applicant
Pom Medical, LLC
Product code
Code CCK
Device class
Class 2
Regulation
21 CFR 868.1400
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Simi Valley, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.