The following data is part of a premarket notification filed by Devilbiss Healthcare Llc with the FDA for Devilbiss Smartlink Ii System.
| Device ID | K140880 |
| 510k Number | K140880 |
| Device Name: | DEVILBISS SMARTLINK II SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | DEVILBISS HEALTHCARE LLC 100 DEVILBISS HEALTHCARE Somerset, PA 15501 |
| Contact | Betty Miller |
| Correspondent | Betty Miller DEVILBISS HEALTHCARE LLC 100 DEVILBISS HEALTHCARE Somerset, PA 15501 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-07 |
| Decision Date | 2014-08-04 |
| Summary: | summary |