The following data is part of a premarket notification filed by Electronic Business Machine Co., Ltd. (ebm) with the FDA for Unisight System With Unigate.
| Device ID | K023394 |
| 510k Number | K023394 |
| Device Name: | UNISIGHT SYSTEM WITH UNIGATE |
| Classification | System, Image Processing, Radiological |
| Applicant | ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) 1600 KAPIDLANI BLVD. SUITE 1224 Honolulu, HI 96814 |
| Contact | David Lin |
| Correspondent | David Lin ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) 1600 KAPIDLANI BLVD. SUITE 1224 Honolulu, HI 96814 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-09 |
| Decision Date | 2003-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719878870108 | K023394 | 000 |