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510(k) K950788

OTOSCOPE A-34 by Neitz Instruments Company, Ltd. — Product Code ERA

K950788 is an FDA 510(k) premarket notification submitted by Neitz Instruments Company, Ltd. for the device "OTOSCOPE A-34". The FDA issued a decision of Substantially Equivalent on May 3, 1995. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Neitz Instruments Company, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1995
Date Received
February 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Otoscope
Device Class
Class I
Regulation Number
874.4770
Review Panel
EN
Submission Type

Other clearances by Neitz Instruments Company, Ltd.

  • K972440 — CATARACTSCREENER CT - S (September 30, 1997)
  • K951341 — NEITZ SLIT LAMP SL-H2 (June 15, 1995)
  • K951337 — FIBER HEAD LIGHT FH-300 (June 8, 1995)
  • K951340 — NEITZ SLIT LAMP SL-H1 (April 10, 1995)
  • K951338 — INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV (April 7, 1995)
  • K950791 — STREAK RETINOSCOPE RX-3 (March 28, 1995)
  • K950792 — STREAK RETINOSCOPE RX-3A (March 28, 1995)
  • K950789 — STREAK RETINOSCOPE RX-1 (March 28, 1995)
  • K950794 — STREAK RETINOSCOPE RX-RC (March 28, 1995)
  • K950797 — HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 (March 28, 1995)

Other clearances for product code ERA

  • K123821 — AIO HD OTOSCOPE (May 17, 2013)
  • K121326 — LANTOS 3D EAR SCANNER (January 25, 2013)
  • K110326 — OSRAM ITOS (October 27, 2011)
  • K945264 — OPTUS OTOSCOPES (February 2, 1996)
  • K955043 — WELCH ALLYN BI-OTOSCOPE (November 14, 1995)
  • K952578 — WELCH ALLY OTOSCOPE (July 10, 1995)
  • K950913 — PERFECT, ENT SET, PRAKTIKANT, DE LUXE (May 12, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951255 — IMEDGE VIDEO OSTOSCOPE (ANALOG) (April 13, 1995)

FDA data resources