Home / 510(k) Clearances / K944156

510(k) K944156

HEINE LAMBDA 100 by Heine USA , Ltd. — Product Code HOX

K944156 is an FDA 510(k) premarket notification submitted by Heine USA , Ltd. for the device "HEINE LAMBDA 100". The FDA issued a decision of Substantially Equivalent on January 12, 1995. The device falls under product code HOX (Chart, Visual Acuity), a Class I device regulated under 21 CFR 886.1150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1995
Date Received
August 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chart, Visual Acuity
Device Class
Class I
Regulation Number
886.1150
Review Panel
OP
Submission Type

Other clearances for product code HOX

  • K100095 — CENTRAL VISION ANALYZER MODEL 1000 (May 10, 2010)
  • K881971 — OCCU-TECH VISION TEST (November 25, 1988)
  • K883337 — PL 20/20 INFANT VISION TESTER (October 31, 1988)
  • K882634 — VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE (July 15, 1988)
  • K881358 — PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM (June 27, 1988)
  • K881059 — MCT 8000 (MULTI-VISION CONTRAST TESTER) (April 4, 1988)
  • K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (April 1, 1988)
  • K881023 — VCTS 6500 SYSTEM (April 1, 1988)
  • K881022 — VCTS MARKETING PROGRAM SYSTEM (April 1, 1988)
  • K881021 — VCTS 700S SYSTEM (April 1, 1988)

FDA data resources