Home / 510(k) Clearances / K905487

510(k) K905487

VARIOUS TYPES OF STETHOSCOPES by Liaoning-Usa Corp. — Product Code LDE

K905487 is an FDA 510(k) premarket notification submitted by Liaoning-Usa Corp. for the device "VARIOUS TYPES OF STETHOSCOPES". The FDA issued a decision of Substantially Equivalent on April 9, 1991. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875. Liaoning-Usa Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1991
Date Received
December 6, 1990
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 Liaoning-Usa Corp.

  • K911921 — DISPOSABLE ISOLATION GOWN (May 13, 1991)
  • K910623 — GAUZE SPONGES ABSORBENT GAUZE ROLLS (April 1, 1991)
  • K902625 — CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT (October 26, 1990)
  • K892781 — ANTELOPE BRAND PATIENT EXAMINATION GLOVES (September 21, 1989)
  • K892774 — PATIENT EXAMINATION GLOVES (September 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)
  • 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)
  • K904547 — STETHOSCOPE (March 21, 1991)
  • K895545 — V*S*R(TM) SCOPE (November 15, 1989)

FDA data resources