The following data is part of a premarket notification filed by Deep Breeze Ltd. with the FDA for Vrlxp, Model Xp.
| Device ID | K091732 |
| 510k Number | K091732 |
| Device Name: | VRLXP, MODEL XP |
| Classification | Lung Sound Monitor |
| Applicant | DEEP BREEZE LTD. 2001 PENNSYLVANIA AVENUE NW SUITE 950 Washington, DC 20006 |
| Contact | Jeff Baetz |
| Correspondent | Jeff Baetz DEEP BREEZE LTD. 2001 PENNSYLVANIA AVENUE NW SUITE 950 Washington, DC 20006 |
| Product Code | OCR |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-11 |
| Decision Date | 2010-03-04 |
| Summary: | summary |