DeviceClearance

OxyMinder— 510(k) K213948

Substantially Equivalent

Bio-Med Devices, Inc.

FDA 510(k) clearance K213948 for OxyMinder, Substantially Equivalent on 2022-03-17. Applicant: Bio-Med Devices, Inc.. Device class: 2.

Clearance details

Applicant
Bio-Med Devices, Inc.
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
Guilford, CT, 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.