510(k) K001223
K001223 is an FDA 510(k) premarket notification submitted by Aculux for the device "ACULUX, MODEL AX3001, AX3002". The FDA issued a decision of Substantially Equivalent on June 23, 2000. The device falls under product code FQP (Lamp, Operating-Room), a Class II device regulated under 21 CFR 878.4580. Aculux has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2000
- Date Received
- April 17, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Operating-Room
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type