Submission Details
| 510(k) Number | K983817 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 1998 |
| Decision Date | March 01, 1999 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
Mar 1999
Decision
123d
Days
Class 2
Risk
About This 510(k) Submission
K983817 is an FDA 510(k) clearance for the BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F), 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 1, 1999, 123 days after receiving the submission on October 29, 1998. 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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