The following data is part of a premarket notification filed by Pneumacare Limited with the FDA for Thora-3di, Model T-01.
| Device ID | K151940 |
| 510k Number | K151940 |
| Device Name: | Thora-3Di, Model T-01 |
| Classification | Monitor, Breathing Frequency |
| Applicant | PneumaCare LIMITED ST. JOHNS INNOVATION CENTRE, COWLEY ROAD Cambridge, GB Cb4 0ws |
| Contact | Mark Harwood |
| Correspondent | Nandini Murthy PneumaCare LIMITED C/O ALACRITA, ONE BROADWAY, 14TH FLOOR, KENDALL SQUARE Cambridge, MA 02142 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-14 |
| Decision Date | 2016-03-10 |
| Summary: | summary |