E.G. SCAN II ESPHAGOSCOPE SYSTEM
FDA 510(k) clearance K120702 · decided 2012-06-20
Clearance details
- K-number
- K120702
- Device name
- E.G. SCAN II ESPHAGOSCOPE SYSTEM
- Applicant
- Intromedic Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-03-08
- Decision date
- 2012-06-20
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- EOX
- Device class
- 2
- Regulation number
- 874.4710
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Guro-Gu , Seoul, KR
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.