510(k) K934728
K934728 is an FDA 510(k) premarket notification submitted by Sunsor, Inc. for the device "SUNSOR ULTRAVIOLET METER". The FDA issued a decision of Substantially Equivalent on July 28, 1994. The device falls under product code EAQ (Detector, Ultraviolet), a Class II device regulated under 21 CFR 872.6350.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1994
- Date Received
- September 29, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector, Ultraviolet
- Device Class
- Class II
- Regulation Number
- 872.6350
- Review Panel
- DE
- Submission Type