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510(k) K882324

STETH-SHIELD ACCESSORY TO A STETHOSCOPE by Steth-Shield, Inc. — Product Code LDE

K882324 is an FDA 510(k) premarket notification submitted by Steth-Shield, Inc. for the device "STETH-SHIELD ACCESSORY TO A STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on July 18, 1988. 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
July 18, 1988
Date Received
June 6, 1988
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