The following data is part of a premarket notification filed by Eresearch Technology with the FDA for Asthma Monitor Am3.
| Device ID | K133722 |
| 510k Number | K133722 |
| Device Name: | ASTHMA MONITOR AM3 |
| Classification | Spirometer, Diagnostic |
| Applicant | ERESEARCH TECHNOLOGY 1818 MARKET STREET, STE 1000 Philadelphia, PA 19103 |
| Contact | Richard A Miller |
| Correspondent | Richard A Miller ERESEARCH TECHNOLOGY 1818 MARKET STREET, STE 1000 Philadelphia, PA 19103 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-05 |
| Decision Date | 2014-05-08 |
| Summary: | summary |