510(k) K843214
K843214 is an FDA 510(k) premarket notification submitted by Akron City Hospital for the device "EPHAR". The FDA issued a decision of Substantially Equivalent on November 29, 1984. The device falls under product code FFI (System, Alarm, Electrosurgical), a Class II device regulated under 21 CFR 876.4300. Akron City Hospital has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1984
- Date Received
- August 15, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Alarm, Electrosurgical
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type