510(k) K994362
K994362 is an FDA 510(k) premarket notification submitted by Angiolaz, Inc. for the device "HEADLAMP HL2000.". The FDA issued a decision of Substantially Equivalent on May 11, 2000. The device falls under product code FSR (Light, Headband, Surgical), a Class II device regulated under 21 CFR 886.4335. Angiolaz, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2000
- Date Received
- December 27, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Headband, Surgical
- Device Class
- Class II
- Regulation Number
- 886.4335
- Review Panel
- OP
- Submission Type