The following data is part of a premarket notification filed by Emc Industries with the FDA for Emc Model Statome 200.
| Device ID | K952231 |
| 510k Number | K952231 |
| Device Name: | EMC MODEL STATOME 200 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EMC INDUSTRIES 1689 MIDDLETON AVE. Los Altos, CA 94024 |
| Contact | Philip R Hardaker |
| Correspondent | Philip R Hardaker EMC INDUSTRIES 1689 MIDDLETON AVE. Los Altos, CA 94024 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-12 |
| Decision Date | 1995-11-21 |