510(k) K901079— SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER

Substantially Equivalent

L H M Ent., Inc.

Clearance details

Applicant: L H M Ent., Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1990-03-07
Decision date: 1990-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, US

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.