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510(k) K854771

SALTZMAN STETHOSCOPE HEAD by K & S Medicorp — Product Code LDE

K854771 is an FDA 510(k) premarket notification submitted by K & S Medicorp for the device "SALTZMAN STETHOSCOPE HEAD". The FDA issued a decision of Substantially Equivalent on May 9, 1986. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875. K & S Medicorp has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1986
Date Received
November 29, 1985
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 K & S Medicorp

  • K862131 — SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR (July 14, 1986)
  • K854772 — TRANSCOR (TM) RADIO-STETHOSCOPE (May 13, 1986)

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