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510(k) K871369

VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES: by Keeler Instruments, Inc. — Product Code LDE

K871369 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:". The FDA issued a decision of Substantially Equivalent on September 24, 1987. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1987
Date Received
April 7, 1987
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 Keeler Instruments, Inc.

  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)
  • K100500 — PSL CLASSIC SLIT LAMP (March 9, 2010)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K060822 — VANTAGE INDIRECT OPHTHALMOSCOPE (May 23, 2006)
  • K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (November 26, 2003)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETER (March 25, 1999)
  • K973064 — KEELER TEARSCOPE-PLUS (April 7, 1998)

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