Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K183479 |
Device Name |
Asthma Monitor AM3 |
Applicant |
eResearchTechnology |
Sieboldstrasse 3 |
Estenfeld,
DE
97230
|
|
Applicant Contact |
Kristin Feld |
Correspondent |
eResearchTechnology |
500 Rutherford Avenue |
Boston,
MA
02129
|
|
Correspondent Contact |
Mingzi Deng |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 12/17/2018 |
Decision Date | 10/03/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|