510(k) K910091
K910091 is an FDA 510(k) premarket notification submitted by Ultralite for the device "ULTRALITE PANELITE". The FDA issued a decision of Substantially Equivalent on May 30, 1991. The device falls under product code IOB (Lamp, Infrared, Non Heating), a Class II device regulated under 21 CFR 890.5500. Ultralite has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1991
- Date Received
- January 9, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Infrared, Non Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type