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510(k) K883337

PL 20/20 INFANT VISION TESTER by Optimed Technologies, Inc. — Product Code HOX

K883337 is an FDA 510(k) premarket notification submitted by Optimed Technologies, Inc. for the device "PL 20/20 INFANT VISION TESTER". The FDA issued a decision of Substantially Equivalent on October 31, 1988. The device falls under product code HOX (Chart, Visual Acuity), a Class I device regulated under 21 CFR 886.1150. Optimed Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1988
Date Received
August 9, 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 Optimed Technologies, Inc.

  • K972520 — OPTIVIEW (September 29, 1997)
  • K955275 — BOOSTER TROPHY 5 MOTORIZED SCOOTER (November 4, 1996)
  • K955276 — BOOSTER LITE 4 MOTORIZED SCOOTER (November 4, 1996)
  • K955274 — BOOSTER LITE 3 MOTORIZED SCOOTER (November 4, 1996)
  • K943598 — FLEXIBLE FIBER OPTIC LAPAROSCOPES (October 18, 1994)
  • K926597 — LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) (July 12, 1994)
  • K921942 — HYSTEROSCOPE (AND ACCESSORIES) (June 24, 1994)
  • K922711 — FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE (May 17, 1994)
  • K921985 — ARTHROSCOPE & ACCESSORIES (June 29, 1993)
  • K922826 — FLEXIBLE FIBER OPTIC ENDOSCOPE (February 19, 1993)

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

FDA data resources