510(k) K843214
- Device
- EPHAR
- Applicant
- AKRON CITY HOSPITAL
- 510(k) number
- K843214
- Product code
- FFI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-11-29
- Date received
- 1984-08-15
- Regulation
- 876.4300
- Classification name
- System, Alarm, Electrosurgical
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIMOTHY A BODNER
- Address
- 525 E. Market St. Akron OH US 44309 44309
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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