The following data is part of a premarket notification filed by Medical Respiratory Devices S.l. with the FDA for Neumofilt Ergo/neumo Filt Biteon.
| Device ID | K142303 |
| 510k Number | K142303 |
| Device Name: | NeumoFilt Ergo/Neumo Filt BiteOn |
| Classification | Spirometer, Diagnostic |
| Applicant | Medical Respiratory Devices S.L. Avda. De Las Americas 4, Nave A7 Coslada(madrid), ES 28823 |
| Contact | Jose Alberto Hernandez |
| Correspondent | Paul Dryden Medical Respiratory Devices S.L. Avda. De Las Americas 4, Nave A7 Coslada(madrid), ES 28823 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-18 |
| Decision Date | 2014-11-20 |
| Summary: | summary |