K843843 is an FDA 510(k) clearance for the HE TEST. This device is classified as a Analyzer, Gas, Helium, Gaseous-phase (Class II - Special Controls, product code BSE).
Submitted by Erich Jaeger, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1984, 64 days after receiving the submission on October 1, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1640.
| 510(k) Number | K843843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1984 |
| Decision Date | December 04, 1984 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BSE — Analyzer, Gas, Helium, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1640 |