The following data is part of a premarket notification filed by Devilbiss Healthcare, Llc with the FDA for Drive Devilbiss Igo 2 Portable Oxygen Concentrator.
| Device ID | K172648 |
| 510k Number | K172648 |
| Device Name: | Drive DeVilbiss IGo 2 Portable Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | DeVilbiss Healthcare, LLC 100 DeVilbiss Drive Somerset, PA 15501 |
| Contact | Betty Miller |
| Correspondent | Sandy Figueroa DeVilbiss Healthcare, LLC 100 DeVilbiss Drive Somerset, PA 15501 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-01 |
| Decision Date | 2018-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885304032502 | K172648 | 000 |
| 00885304022237 | K172648 | 000 |