The following data is part of a premarket notification filed by Velopex International, Inc. with the FDA for Xtender Film Processor, Sprint Film Processor Model Xtender Model Sprint.
| Device ID | K111167 |
| 510k Number | K111167 |
| Device Name: | XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT |
| Classification | Processor, Radiographic-film, Automatic |
| Applicant | VELOPEX INTERNATIONAL, INC. 105 EAST 17TH ST. St. Cloud, FL 34769 |
| Contact | Anthony Urella |
| Correspondent | Anthony Urella VELOPEX INTERNATIONAL, INC. 105 EAST 17TH ST. St. Cloud, FL 34769 |
| Product Code | IXW |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-26 |
| Decision Date | 2011-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060209580814 | K111167 | 000 |