The following data is part of a premarket notification filed by Eumedics Medizintechnik Und Marketing Gmbh with the FDA for Respifit S, Model Rs-lr1001004.
Device ID | K080299 |
510k Number | K080299 |
Device Name: | RESPIFIT S, MODEL RS-LR1001004 |
Classification | Spirometer, Therapeutic (incentive) |
Applicant | EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH 1341 W FULLERTON SUITE 103 Chicago, IL 60014 |
Contact | David Levine |
Correspondent | David Levine EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH 1341 W FULLERTON SUITE 103 Chicago, IL 60014 |
Product Code | BWF |
CFR Regulation Number | 868.5690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-02-05 |
Decision Date | 2009-01-13 |
Summary: | summary |