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 |