Clearance Summary
EPITOME SYSTEM received FDA 510(k) clearance under submission number K041206, sponsored by Gebauer Medizintechnik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2004-09-15.
- Submission: K041206
- Applicant / Sponsor: Gebauer Medizintechnik GmbH
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2004-09-15
Classification & Regulation
This clearance is catalogued under FDA product code HNO and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.