The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-cord.
| Device ID | K141225 |
| 510k Number | K141225 |
| Device Name: | ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLYMPUS WINTER & IBE GMBH 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Graham A L Baillie |
| Correspondent | Graham A L Baillie OLYMPUS WINTER & IBE GMBH 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-12 |
| Decision Date | 2014-08-12 |
| Summary: | summary |