The following data is part of a premarket notification filed by Akron City Hospital with the FDA for Ephar.
| Device ID | K843214 |
| 510k Number | K843214 |
| Device Name: | EPHAR |
| Classification | System, Alarm, Electrosurgical |
| Applicant | AKRON CITY HOSPITAL 525 E. MARKET ST. Akron, OH 44309 |
| Contact | Timothy A Bodner |
| Correspondent | Timothy A Bodner AKRON CITY HOSPITAL 525 E. MARKET ST. Akron, OH 44309 |
| Product Code | FFI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-15 |
| Decision Date | 1984-11-29 |