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510(k) K860473

DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE by Schering Corp. — Product Code LDE

K860473 is an FDA 510(k) premarket notification submitted by Schering Corp. for the device "DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE". The FDA issued a decision of Substantially Equivalent on August 14, 1986. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1986
Date Received
February 6, 1986
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 for product code LDE

  • K945082 — CYPRESS MEDICAL PRODUCTS STETHOSCOPE (December 8, 1994)
  • K944337 — VARIOUS STETHOSCOPES (November 30, 1994)
  • K940578 — MANUAL STETOSCOPE (April 26, 1994)
  • K935944 — PROSCOPES AND ADSCOPES (March 3, 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)

FDA data resources