The following data is part of a premarket notification filed by Eresearchtechnology with the FDA for Asthma Monitor Am3.
| Device ID | K183479 |
| 510k Number | K183479 |
| Device Name: | Asthma Monitor AM3 |
| Classification | Spirometer, Diagnostic |
| Applicant | eResearchTechnology Sieboldstrasse 3 Estenfeld, DE 97230 |
| Contact | Kristin Feld |
| Correspondent | Mingzi Deng eResearchTechnology 500 Rutherford Avenue Boston, MA 02129 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057155000603 | K183479 | 000 |
| 04057155000207 | K183479 | 000 |