Submission Details
| 510(k) Number | K031176 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 14, 2003 |
| Decision Date | March 25, 2004 |
| Days to Decision | 346 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
Mar 2004
Decision
346d
Days
Class 2
Risk
About This 510(k) Submission
K031176 is an FDA 510(k) clearance for the INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on March 25, 2004, 346 days after receiving the submission on April 14, 2003. 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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