EPHAR
FDA 510(k) clearance K843214 · decided 1984-11-29
Clearance details
- K-number
- K843214
- Device name
- EPHAR
- Applicant
- Akron City Hospital
- Decision
- Substantially Equivalent
- Date received
- 1984-08-15
- Decision date
- 1984-11-29
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- FFI
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.