Submission Details
| 510(k) Number | K960035 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 03, 1996 |
| Decision Date | April 08, 1996 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
CARBON DIOXIDE - DST
Apr 1996
Decision
96d
Days
Class 2
Risk
About This 510(k) Submission
K960035 is an FDA 510(k) clearance for the CARBON DIOXIDE - DST, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on April 8, 1996, 96 days after receiving the submission on January 3, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.
Device Classification
| Product Code | KHS — Enzymatic, Carbon-dioxide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1160 |
Manufacturer
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