DeviceClearance

OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)— 510(k) K882743

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K882743 for OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR), Substantially Equivalent on 1988-08-24. Applicant: Ohmeda Medical. Device class: 2.

Clearance details

Applicant
Ohmeda Medical
Product code
Code CCL
Device class
Class 2
Regulation
21 CFR 868.1720
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Englewood, CO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CCL

product code CCL
Other
2
Total
2

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.