The following data is part of a premarket notification filed by Swissray International, Inc. with the FDA for Ddrcompact, Ddrcompact Plus And Ddrcompact Chest.
| Device ID | K070678 |
| 510k Number | K070678 |
| Device Name: | DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST |
| Classification | System, X-ray, Stationary |
| Applicant | SWISSRAY INTERNATIONAL, INC. 1180 MCLESTER STREET, UNIT#2 Elizabeth, NJ 07201 |
| Contact | John Monahan |
| Correspondent | John Monahan SWISSRAY INTERNATIONAL, INC. 1180 MCLESTER STREET, UNIT#2 Elizabeth, NJ 07201 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-12 |
| Decision Date | 2007-05-02 |