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510(k) K093495

OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS by American Diagnostic Corp. — Product Code HLJ

K093495 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS". The FDA issued a decision of Substantially Equivalent on November 19, 2010. The device falls under product code HLJ (Ophthalmoscope, Battery-Powered), a Class II device regulated under 21 CFR 886.1570. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2010
Date Received
November 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by American Diagnostic Corp.

  • K162589 — Adscope 658 Electronic Stethoscope (March 10, 2017)
  • K060321 — ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK (May 15, 2006)
  • K012304 — ADC 656 ELECTRONIC STETHOSCOPE (November 1, 2001)
  • K962655 — ANEROID AND MERCURIAL SPHYGMOMANOMETERS (January 27, 1997)
  • K940686 — ELECTRONIC THERMOMETERS (July 8, 1994)
  • K935944 — PROSCOPES AND ADSCOPES (March 3, 1994)
  • K932145 — COAGULATION REFERENCE PLASMA, NORMAL (October 18, 1993)
  • K894169 — BIOTEL MICROALBUMINURIA (TM) (September 18, 1989)
  • K893608 — ACTICHROME ATIII KIT (June 23, 1989)
  • K884940 — RELLPLATE C KIT, RELLPLATE C BULK PLATES (March 13, 1989)

Other clearances for product code HLJ

  • K142486 — HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 (May 18, 2015)
  • K142837 — HEINE SIGMA 250 & HEINE SIGMA 250 M2 (January 29, 2015)
  • K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPE (March 7, 2014)
  • K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE (December 4, 2013)
  • K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS (October 30, 2013)
  • K123587 — HEINE MINI 3000 LED OPHTHALMOSCOPE (March 22, 2013)
  • K070270 — PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 (November 5, 2007)
  • K052599 — 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25 (November 7, 2006)
  • K061278 — OPTYSE OPHTHALMOSCOPE (May 16, 2006)
  • K053425 — PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS (January 9, 2006)

FDA data resources