Submission Details
| 510(k) Number | K941676 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 05, 1994 |
| Decision Date | May 20, 1994 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
STERIVENT AND STERIVENT S
May 1994
Decision
45d
Days
Class 2
Risk
About This 510(k) Submission
K941676 is an FDA 510(k) clearance for the STERIVENT AND STERIVENT S, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Mallinckrodt Medical (Argyle, US). The FDA issued a Cleared decision on May 20, 1994, 45 days after receiving the submission on April 5, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.
Device Classification
| Product Code | CAH — Filter, Bacterial, Breathing-circuit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5260 |
Manufacturer
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