Home / 510(k) Clearances / K994362

510(k) K994362

HEADLAMP HL2000. by Angiolaz, Inc. — Product Code FSR

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

Other clearances by Angiolaz, Inc.

  • K992447 — 50 W METAL HALIDE ILLUMINATOR, VES 0501. (October 20, 1999)
  • K982397 — VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM (September 10, 1998)
  • K982409 — VES 1501-M (August 21, 1998)
  • K981819 — ANGIOLAZ VES-1CAM (August 4, 1998)
  • K981821 — VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (July 29, 1998)
  • K981827 — VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM (July 28, 1998)
  • K933868 — ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES (November 10, 1993)
  • K913129 — ANGIOLAZ ANGIOSCOPE CATHETER (December 27, 1991)
  • K902329 — ULTRA-VU ANGIOSCOPE (August 22, 1990)

Other clearances for product code FSR

  • K110528 — INTEGRA LED SURGICAL HEADLIGHT SYSTEM (May 11, 2011)
  • K031549 — SOLID STATE LAMP [LED] HEADLIGHT (August 11, 2003)
  • K031548 — LED HEADLIGHT (August 11, 2003)