The following data is part of a premarket notification filed by Ndd Medizitechnik Ag with the FDA for Easy On-pc Spirometer.
| Device ID | K090034 |
| 510k Number | K090034 |
| Device Name: | EASY ON-PC SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | NDD MEDIZITECHNIK AG TWO DUNDEE PARK Andover, MA 01810 |
| Contact | Jerry Masiello |
| Correspondent | Jerry Masiello NDD MEDIZITECHNIK AG TWO DUNDEE PARK Andover, MA 01810 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-06 |
| Decision Date | 2009-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640142190301 | K090034 | 000 |
| 20612479194438 | K090034 | 000 |