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510(k) K920069

MAGNI-CAM by Innoventions, Inc. — Product Code HJG

K920069 is an FDA 510(k) premarket notification submitted by Innoventions, Inc. for the device "MAGNI-CAM". The FDA issued a decision of Substantially Equivalent on March 2, 1992. The device falls under product code HJG (System, Reading, Television, Closed-Circuit), a Class I device regulated under 21 CFR 886.5820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1992
Date Received
January 7, 1992
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 for product code HJG

  • K933633 — LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE (February 22, 1994)
  • K915340 — MENTOR HORIZON LOW VISION MAGNIFIER (March 30, 1992)
  • K892350 — MAGNILINK SYSTEM 402/5 (May 26, 1989)
  • K892348 — MAGNILINK SYSTEM 201 (May 26, 1989)
  • K892349 — MAGNILINK SYSTEM 209 (May 26, 1989)
  • K892347 — MAGNILINK SYSTEM 101 (May 26, 1989)
  • K892351 — MAGNILINK SYSTEM 602 (May 26, 1989)

FDA data resources