DeviceClearance

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly— 510(k) K180902

Substantially Equivalent

Medipines Corporation

FDA 510(k) clearance K180902 for MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly, Substantially Equivalent on 2019-01-11. Applicant: Medipines Corporation. Device class: 2.

Clearance details

Applicant
Medipines Corporation
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
Anaheim Hill, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CCK

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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.