OMICRON MONITOR, DELTA MONITOR— 510(k) K960861

Substantially Equivalent - Subject to Tracking Reg.

Core-M, Inc.

FDA 510(k) clearance K960861 for OMICRON MONITOR, DELTA MONITOR, Substantially Equivalent - Subject to Tracking Reg. on 1996-08-19. Applicant: Core-M, Inc..

Clearance details

Applicant: Core-M, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 1996-03-01
Decision date: 1996-08-19
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Allston, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.