The following data is part of a premarket notification filed by Ndd Medizitechnik Ag with the FDA for Easyone Pro Respiratory Testing Device.
| Device ID | K120635 |
| 510k Number | K120635 |
| Device Name: | EASYONE PRO RESPIRATORY TESTING DEVICE |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | NDD MEDIZITECHNIK AG TWO DUNDEE PARK Andover, MA 01810 |
| Contact | Gerard Masiello |
| Correspondent | Gerard Masiello NDD MEDIZITECHNIK AG TWO DUNDEE PARK Andover, MA 01810 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-01 |
| Decision Date | 2012-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640142190370 | K120635 | 000 |