Submission Details
| 510(k) Number | K010040 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 05, 2001 |
| Decision Date | March 09, 2001 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
SLEEVED FILTER
Mar 2001
Decision
63d
Days
Class 2
Risk
About This 510(k) Submission
K010040 is an FDA 510(k) clearance for the SLEEVED FILTER, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on March 9, 2001, 63 days after receiving the submission on January 5, 2001. 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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