The following data is part of a premarket notification filed by Vbox, Inc. with the FDA for Trooper Oxygen Concentrator.
| Device ID | K121260 |
| 510k Number | K121260 |
| Device Name: | TROOPER OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | VBOX, INC. 2342 EAST COUNTY ROAD J White Bear Lake, MN 55110 |
| Contact | Theodore Jagger |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-04-26 |
| Decision Date | 2012-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853041003000 | K121260 | 000 |