The following data is part of a premarket notification filed by Pulmone Advanced Medical Devices, Ltd with the FDA for Pulmone Minibox Pft Tm.
| Device ID | K133051 |
| 510k Number | K133051 |
| Device Name: | PULMONE MINIBOX PFT TM |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | PULMONE ADVANCED MEDICAL DEVICES, LTD 12154 DARNESTOWN RD, #236 Gaithersburg, MD 20878 |
| Contact | Rhona Shanker |
| Correspondent | Rhona Shanker PULMONE ADVANCED MEDICAL DEVICES, LTD 12154 DARNESTOWN RD, #236 Gaithersburg, MD 20878 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2014-05-02 |
| Summary: | summary |