Submission Details
| 510(k) Number | K871618 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 1987 |
| Decision Date | May 08, 1987 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
Cleared
Traditional
PREFILLED STERILE WATER FOR INHALATION, USP
May 1987
Decision
11d
Days
Class 2
Risk
About This 510(k) Submission
K871618 is an FDA 510(k) clearance for the PREFILLED STERILE WATER FOR INHALATION, 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 May 8, 1987, 11 days after receiving the submission on April 27, 1987. 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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