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

Name: FDA 510(k) clearance K853146
Creator: U.S. Food and Drug Administration
Published: 1985-08-06

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.. Device class: 2.

Clearance details

Applicant: Automatic Liquid Packaging, Inc.
Product code: Code BTT
Device class: Class 2
Regulation: 21 CFR 868.5450
Advisory panel: Anesthesiology
Date received: 1985-07-29
Decision date: 1985-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Automatic Liquid Packaging, Inc.

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K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP2000-10-25
K000964 — STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL41092000-04-25
K980147 — YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION1998-04-13
K973829 — IRRIGATION BOTTLE1998-02-23
K962079 — HUMIDIFIER ADAPTER1996-07-31

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.