The following data is part of a premarket notification filed by Pulmone Advanced Medical Devices, Ltd with the FDA for Minibox +.
| Device ID | K161295 |
| 510k Number | K161295 |
| Device Name: | MiniBox + |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | PULMONE ADVANCED MEDICAL DEVICES, LTD 14 HACHAROSHET ST Ra’ananna, IL 4365707 |
| Contact | Avi Lazar |
| Correspondent | Susan Alpert SFA CONSULTING, LLC 200 PARK AVENUE, UNIT 111 Minneapolis, MN 55415 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-09 |
| Decision Date | 2016-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016675016 | K161295 | 000 |