K843849 is an FDA 510(k) clearance for the PNEUMOSCREEN. This device is classified as a Calculator, Pulmonary Function Data (Class II - Special Controls, product code BZC).
Submitted by Erich Jaeger, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 16, 1984, 15 days after receiving the submission on October 1, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1880.
| 510(k) Number | K843849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1984 |
| Decision Date | October 16, 1984 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZC — Calculator, Pulmonary Function Data |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1880 |