Submission Details
| 510(k) Number | K952410 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 24, 1995 |
| Decision Date | October 05, 1995 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
CARBON DIOXIDE - DST
Oct 1995
Decision
134d
Days
Class 2
Risk
About This 510(k) Submission
K952410 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 October 5, 1995, 134 days after receiving the submission on May 24, 1995. 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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