Submission Details
| 510(k) Number | K963025 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 05, 1996 |
| Decision Date | November 01, 1996 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
Cleared
Traditional
SLEEPNET HUMIDIFIER,(84200 PACKAGED)
Nov 1996
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K963025 is an FDA 510(k) clearance for the SLEEPNET HUMIDIFIER,(84200 PACKAGED), a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Sleepnet Corporation (Manchester, US). The FDA issued a Cleared decision on November 1, 1996, 88 days after receiving the submission on August 5, 1996. 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 |
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