Clearance Summary
71110 DESK CHARGER received FDA 510(k) clearance under submission number K771900, sponsored by Welch Allyn, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1977-11-09.
- Submission: K771900
- Applicant / Sponsor: Welch Allyn, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1270
- Decision date: 1977-11-09
Classification & Regulation
This clearance is catalogued under FDA product code HLS and 21 CFR 886.1270, within the Ophthalmic review panel as a Class I device.