510(k) K932193— PEDIATRIC TEMPERATURE MONITORING CIRCUITS

Substantially Equivalent

Life Shield Healthcare Products, Inc.

Clearance details

Applicant: Life Shield Healthcare Products, Inc.
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1993-05-06
Decision date: 1993-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noblesville, IN, US

Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.