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 |