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510(k) K875112

MENTOR B-VAT(TM) II VIDEO TESTER by Mentor O & O, Inc. — Product Code HOX

K875112 is an FDA 510(k) premarket notification submitted by Mentor O & O, Inc. for the device "MENTOR B-VAT(TM) II VIDEO TESTER". The FDA issued a decision of Substantially Equivalent on March 8, 1988. The device falls under product code HOX (Chart, Visual Acuity), a Class I device regulated under 21 CFR 886.1150. Mentor O & O, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1988
Date Received
December 15, 1987
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 by Mentor O & O, Inc.

  • K955245 — MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM (February 12, 1996)
  • K934320 — MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION A (February 16, 1994)
  • K912904 — MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM (June 11, 1992)
  • K915340 — MENTOR HORIZON LOW VISION MAGNIFIER (March 30, 1992)
  • K910637 — MENTOR(R) SUR-E-TROL(R) (May 13, 1991)
  • K911160 — MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 (May 2, 1991)
  • K903878 — MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT (November 5, 1990)
  • K895010 — MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE (September 11, 1989)
  • K890622 — SURG-E-TROL SYSTEM I AND SYSTEM II (May 4, 1989)
  • K890595 — MENTOR ANTERIOR SEGMENT VITRECTOR (April 17, 1989)

Other clearances for product code HOX

  • K100095 — CENTRAL VISION ANALYZER MODEL 1000 (May 10, 2010)
  • K944156 — HEINE LAMBDA 100 (January 12, 1995)
  • 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)
  • K881023 — VCTS 6500 SYSTEM (April 1, 1988)
  • K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (April 1, 1988)
  • K881021 — VCTS 700S SYSTEM (April 1, 1988)

FDA data resources