Submission Details
| 510(k) Number | K941381 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 1994 |
| Decision Date | April 15, 1994 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
HYGROBAC,S HYGROBOY AND HYGROBABY
Apr 1994
Decision
24d
Days
Class 2
Risk
About This 510(k) Submission
K941381 is an FDA 510(k) clearance for the HYGROBAC,S HYGROBOY AND HYGROBABY, 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 April 15, 1994, 24 days after receiving the submission on March 22, 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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