510(k) K951337
K951337 is an FDA 510(k) premarket notification submitted by Neitz Instruments Company, Ltd. for the device "FIBER HEAD LIGHT FH-300". The FDA issued a decision of Substantially Equivalent on June 8, 1995. The device falls under product code HPQ (Headlamp, Operating, Ac-Powered), a Class II device regulated under 21 CFR 886.4335. Neitz Instruments Company, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1995
- Date Received
- March 24, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Headlamp, Operating, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.4335
- Review Panel
- OP
- Submission Type