The following data is part of a premarket notification filed by Swissray Medical Ag with the FDA for Ddrformula And Ddrformula Plus.
| Device ID | K052943 |
| 510k Number | K052943 |
| Device Name: | DDRFORMULA AND DDRFORMULA PLUS |
| Classification | System, X-ray, Stationary |
| Applicant | SWISSRAY MEDICAL AG 1180 MCLESTER STREET, UNIT #2 Elizabeth, NJ 07201 |
| Contact | John Monahan |
| Correspondent | John Monahan SWISSRAY MEDICAL AG 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 | 2005-10-20 |
| Decision Date | 2005-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011334620 | K052943 | 000 |