The following data is part of a premarket notification filed by Erich Jaeger Gmbh & Co. Kg with the FDA for Asthma Monitor Am2.
| Device ID | K980876 |
| 510k Number | K980876 |
| Device Name: | ASTHMA MONITOR AM2 |
| Classification | Spirometer, Diagnostic |
| Applicant | ERICH JAEGER GMBH & CO. KG LEIBNIZSTRASSE 7 Hoechberg, DE D-97204 |
| Contact | Detlef Grotheer |
| Correspondent | Detlef Grotheer ERICH JAEGER GMBH & CO. KG LEIBNIZSTRASSE 7 Hoechberg, DE D-97204 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-06 |
| Decision Date | 1998-08-14 |