The following data is part of a premarket notification filed by Ndd Medizintechnik Ag with the FDA for Easyone Air Spirometer.
| Device ID | K161536 |
| 510k Number | K161536 |
| Device Name: | EasyOne Air Spirometer |
| Classification | Spirometer, Diagnostic |
| Applicant | NDD MEDIZINTECHNIK AG TECHNOPARKSTRASSE 1 Zurich, CH 8005 |
| Contact | Jerry Masiello |
| Correspondent | Jerry Masiello NDD MEDICAL TECHNOLOGIES 300 BRICKSTONE SQUARE, SUITE 604 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 | 2016-06-03 |
| Decision Date | 2017-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040061954 | K161536 | 000 |
| 07640142190431 | K161536 | 000 |
| 10612479220451 | K161536 | 000 |