K980367 is an FDA 510(k) clearance for the AEROSET SYSTEM. This device is classified as a Electrode, Ion-specific, Chloride (Class II - Special Controls, product code CGZ).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on April 1, 1998, 62 days after receiving the submission on January 29, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K980367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1998 |
| Decision Date | April 01, 1998 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGZ — Electrode, Ion-specific, Chloride |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1170 |