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510(k) K933633

LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE by Gracefully Yours, Inc. — Product Code HJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
July 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Reading, Television, Closed-Circuit
Device Class
Class I
Regulation Number
886.5820
Review Panel
OP
Submission Type

Other clearances by Gracefully Yours, Inc.

  • K941659 — AURAL-CAM, VIDEO EAR, VID RX (April 26, 1994)

Other clearances for product code HJG

  • K915340 — MENTOR HORIZON LOW VISION MAGNIFIER (March 30, 1992)
  • K920069 — MAGNI-CAM (March 2, 1992)
  • K892347 — MAGNILINK SYSTEM 101 (May 26, 1989)
  • K892349 — MAGNILINK SYSTEM 209 (May 26, 1989)
  • K892348 — MAGNILINK SYSTEM 201 (May 26, 1989)
  • K892351 — MAGNILINK SYSTEM 602 (May 26, 1989)
  • K892350 — MAGNILINK SYSTEM 402/5 (May 26, 1989)