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510(k) K935944

PROSCOPES AND ADSCOPES by American Diagnostic Corp. — Product Code LDE

K935944 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "PROSCOPES AND ADSCOPES". The FDA issued a decision of Substantially Equivalent on March 3, 1994. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1994
Date Received
December 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Manual
Device Class
Class I
Regulation Number
870.1875
Review Panel
CV
Submission Type

Other clearances by American Diagnostic Corp.

  • K162589 — Adscope 658 Electronic Stethoscope (March 10, 2017)
  • K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (November 19, 2010)
  • 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)
  • 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 LDE

  • K945082 — CYPRESS MEDICAL PRODUCTS STETHOSCOPE (December 8, 1994)
  • K944337 — VARIOUS STETHOSCOPES (November 30, 1994)
  • K940578 — MANUAL STETOSCOPE (April 26, 1994)
  • K923327 — STETHOSCOPE COVER (November 3, 1992)
  • K924095 — TIMEOSCOPE AND FLEXISCOPE (October 20, 1992)
  • K914100 — STETHOSCOPE (November 7, 1991)
  • K912128 — MAXI-SCOPE OR ULTRA-SCOPE (June 28, 1991)
  • K905487 — VARIOUS TYPES OF STETHOSCOPES (April 9, 1991)
  • K904547 — STETHOSCOPE (March 21, 1991)
  • K895545 — V*S*R(TM) SCOPE (November 15, 1989)

FDA data resources