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510(k) K945082

CYPRESS MEDICAL PRODUCTS STETHOSCOPE by Cypress Medical Products, Ltd. — Product Code LDE

K945082 is an FDA 510(k) premarket notification submitted by Cypress Medical Products, Ltd. for the device "CYPRESS MEDICAL PRODUCTS STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on December 8, 1994. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875. Cypress Medical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1994
Date Received
October 17, 1994
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 Cypress Medical Products, Ltd.

  • K021676 — CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL (July 12, 2002)
  • K012282 — STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE (August 6, 2001)
  • K972899 — CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER (July 7, 1998)
  • K972849 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (May 28, 1998)
  • K972883 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (February 26, 1998)
  • K952367 — CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE (July 5, 1995)
  • K950254 — CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE (March 31, 1995)
  • K950092 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY (February 27, 1995)
  • K950109 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER (February 27, 1995)
  • K921988 — LACERATION REPAIR TRAY (November 19, 1992)

Other clearances for product code LDE

  • 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)
  • K895545 — V*S*R(TM) SCOPE (November 15, 1989)

FDA data resources