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510(k) K895545

V*S*R(TM) SCOPE by Vsr Enterprises Corp. — Product Code LDE

K895545 is an FDA 510(k) premarket notification submitted by Vsr Enterprises Corp. for the device "V*S*R(TM) SCOPE". The FDA issued a decision of Substantially Equivalent on Nov 15, 1989. 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
Nov 15, 1989
Date Received
Sep 13, 1989
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 (Dec 8, 1994)
  • K944337 — VARIOUS STETHOSCOPES (Nov 30, 1994)
  • K940578 — MANUAL STETOSCOPE (Apr 26, 1994)
  • K935944 — PROSCOPES AND ADSCOPES (Mar 3, 1994)
  • K923327 — STETHOSCOPE COVER (Nov 3, 1992)
  • K924095 — TIMEOSCOPE AND FLEXISCOPE (Oct 20, 1992)
  • K914100 — STETHOSCOPE (Nov 7, 1991)
  • K912128 — MAXI-SCOPE OR ULTRA-SCOPE (Jun 28, 1991)
  • K905487 — VARIOUS TYPES OF STETHOSCOPES (Apr 9, 1991)
  • K904547 — STETHOSCOPE (Mar 21, 1991)

FDA data resources