The following data is part of a premarket notification filed by Devilbiss Healthcare, Llc with the FDA for Devilbiss Dv6wm Wireless Modem.
| Device ID | K152810 |
| 510k Number | K152810 |
| Device Name: | DeVilbiss DV6WM Wireless Modem |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | DeVilbiss Healthcare, LLC 100 DeVilbiss Drive Somerset, PA 15501 |
| Contact | Betty Miller |
| Correspondent | Paul Dryden DeVilbiss Healthcare, LLC 100 DeVilbiss Drive 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 | 2015-09-28 |
| Decision Date | 2016-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885304008590 | K152810 | 000 |