Submission Details
| 510(k) Number | K962045 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 28, 1996 |
| Decision Date | November 26, 1996 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
Nov 1996
Decision
182d
Days
Class 2
Risk
About This 510(k) Submission
K962045 is an FDA 510(k) clearance for the ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on November 26, 1996, 182 days after receiving the submission on May 28, 1996. 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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