510(k) K980044
K980044 is an FDA 510(k) premarket notification submitted by Perkinelmer Optoelectronics for the device "XENON 300MX". The FDA issued a decision of Substantially Equivalent on April 3, 1998. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Perkinelmer Optoelectronics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 1998
- Date Received
- January 6, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Floor Standing
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type