510(k) K031549
K031549 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "SOLID STATE LAMP [LED] HEADLIGHT". The FDA issued a decision of Substantially Equivalent on August 11, 2003. The device falls under product code FSR (Light, Headband, Surgical), a Class II device regulated under 21 CFR 886.4335. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2003
- Date Received
- May 16, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Headband, Surgical
- Device Class
- Class II
- Regulation Number
- 886.4335
- Review Panel
- OP
- Submission Type