The following data is part of a premarket notification filed by Pulmone Advanced Medical Devices, Ltd. with the FDA for Pulmone Miniboxpft 2.0.
| Device ID | K141793 |
| 510k Number | K141793 |
| Device Name: | PULMONE MINIBOXPFT 2.0 |
| Classification | Spirometer, Diagnostic |
| Applicant | PULMONE ADVANCED MEDICAL DEVICES, LTD. 200 PARK AVE, UNIT 403 Minneapolis, MN 55415 |
| Contact | Susan Alpert |
| Correspondent | Susan Alpert PULMONE ADVANCED MEDICAL DEVICES, LTD. 200 PARK AVE, UNIT 403 Minneapolis, MN 55415 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2015-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016675009 | K141793 | 000 |