M-2 OXYGEN/TEMPERATURE MONITOR— 510(k) K871337

Substantially Equivalent

Bio-Med Devices, Inc.

FDA 510(k) clearance K871337 for M-2 OXYGEN/TEMPERATURE MONITOR, Substantially Equivalent on 1987-06-05. Applicant: Bio-Med Devices, Inc..

Clearance details

Applicant: Bio-Med Devices, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1987-04-03
Decision date: 1987-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

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.