The following data is part of a premarket notification filed by Dental X-ray Support Systems, Inc. with the FDA for Dxss Automatic X-ray Film Processor, (models #s: 512, 1530, 812, 830).
| Device ID | K992896 |
| 510k Number | K992896 |
| Device Name: | DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) |
| Classification | Processor, Radiographic-film, Automatic, Dental |
| Applicant | DENTAL X-RAY SUPPORT SYSTEMS, INC. 2124 - 196TH ST. S.W., SUITE B Lynnwood, WA 98036 -7006 |
| Contact | Jum Jacobson |
| Correspondent | Jum Jacobson DENTAL X-RAY SUPPORT SYSTEMS, INC. 2124 - 196TH ST. S.W., SUITE B Lynnwood, WA 98036 -7006 |
| Product Code | EGY |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-27 |
| Decision Date | 1999-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862879000303 | K992896 | 000 |