510(k) K112271 ยท BZD Ventilator, Non-Continuous (Respirator)
3B WILLOW
| Applicant | 3B Products, LLC, Lake Wales FL, US |
| Decision | Substantially Equivalent, Feb 16, 2012 |
| Received | Aug 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112271
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2026 | 3B Medical, Inc. Brand Name: Rio" II
Product Name: Rio" II Nasal Pillows Interface
Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large)
Software Version: N/A
Product Description: Nasal pillows inte Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.