K980876 is an FDA 510(k) clearance for the ASTHMA MONITOR AM2. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Erich Jaeger GmbH & Co. KG (Hoechberg, DE). The FDA issued a Cleared decision on August 14, 1998, 161 days after receiving the submission on March 6, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K980876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1998 |
| Decision Date | August 14, 1998 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZG — Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |