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510(k) K881358

PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM by Neuroscientific Corp. — Product Code HOX

K881358 is an FDA 510(k) premarket notification submitted by Neuroscientific Corp. for the device "PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM". The FDA issued a decision of Substantially Equivalent on June 27, 1988. The device falls under product code HOX (Chart, Visual Acuity), a Class I device regulated under 21 CFR 886.1150. Neuroscientific Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1988
Date Received
March 31, 1988
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 Neuroscientific Corp.

  • K880773 — THE VENUS SYSTEM (August 18, 1988)

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)
  • 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)
  • K881022 — VCTS MARKETING PROGRAM SYSTEM (April 1, 1988)
  • K881021 — VCTS 700S SYSTEM (April 1, 1988)

FDA data resources