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510(k) K912128

MAXI-SCOPE OR ULTRA-SCOPE by Seiichi Mfg., Inc. — Product Code LDE

K912128 is an FDA 510(k) premarket notification submitted by Seiichi Mfg., Inc. for the device "MAXI-SCOPE OR ULTRA-SCOPE". The FDA issued a decision of Substantially Equivalent on June 28, 1991. 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
June 28, 1991
Date Received
May 14, 1991
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)
  • 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