Submission Details
| 510(k) Number | K853146 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 1985 |
| Decision Date | August 06, 1985 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
Cleared
Traditional
RESPIR THER HUMID CONTAIN STERILE WATER FOR USP
Aug 1985
Decision
8d
Days
Class 2
Risk
About This 510(k) Submission
K853146 is an FDA 510(k) clearance for the RESPIR THER HUMID CONTAIN STERILE WATER FOR USP, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on August 6, 1985, 8 days after receiving the submission on July 29, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.
Device Classification
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5450 |
Manufacturer
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