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510(k) K843324

SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH by Cher Mel Corp. — Product Code LDE

K843324 is an FDA 510(k) premarket notification submitted by Cher Mel Corp. for the device "SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH". The FDA issued a decision of Substantially Equivalent on June 6, 1985. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875. Cher Mel Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1985
Date Received
August 24, 1984
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 Cher Mel Corp.

  • K863040 — DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS (October 31, 1986)
  • K851516 — CHERMEL SCALP VEIN SET (August 23, 1985)
  • K842203 — LITTMAN TYPE SH-6010, NURSE TYPE (June 6, 1985)
  • K842824 — CHERMEL BONE CHISELS (August 2, 1984)
  • K842822 — CHERMEL BONE GOUGES (August 2, 1984)
  • K842823 — CHERMEL OSTEOTOMES (August 2, 1984)

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