RESPIR THER HUMID CONTAIN STERILE WATER FOR USP— 510(k) K853146

Substantially Equivalent

Automatic Liquid Packaging, Inc.

FDA 510(k) clearance K853146 for RESPIR THER HUMID CONTAIN STERILE WATER FOR USP, Substantially Equivalent on 1985-08-06. Applicant: Automatic Liquid Packaging, Inc..

Clearance details

Applicant: Automatic Liquid Packaging, Inc.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 1985-07-29
Decision date: 1985-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, IL, US

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Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.