The following data is part of a premarket notification filed by 3d Line Usa, Inc. with the FDA for Ergo Srs.
Device ID | K031281 |
510k Number | K031281 |
Device Name: | ERGO SRS |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | 3D LINE USA, INC. 11419 CROWNRIDGE RD., STE.15 Owings Mills, MD 21117 |
Contact | Nader Salehi |
Correspondent | Nader Salehi 3D LINE USA, INC. 11419 CROWNRIDGE RD., STE.15 Owings Mills, MD 21117 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-04-22 |
Decision Date | 2003-12-23 |
Summary: | summary |