The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Smarto.
| Device ID | K101563 |
| 510k Number | K101563 |
| Device Name: | SMARTO |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | JEIL MEDICAL CORPORATION 1006 DIGITAL 2CHA VALLEY BYUCKSAN, GASAN- DONG, GEUMCHE Seoul, KR |
| Contact | Kim Seong Nam |
| Correspondent | Kim Seong Nam JEIL MEDICAL CORPORATION 1006 DIGITAL 2CHA VALLEY BYUCKSAN, GASAN- DONG, GEUMCHE Seoul, KR |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-04 |
| Decision Date | 2010-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711LS5720 | K101563 | 000 |