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510(k) K944897

HOME CARE EAR EXAMINATIO KIT by Home Care Instruments, Inc. — Product Code ERA

K944897 is an FDA 510(k) premarket notification submitted by Home Care Instruments, Inc. for the device "HOME CARE EAR EXAMINATIO KIT". The FDA issued a decision of Substantially Equivalent on November 8, 1994. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1994
Date Received
October 4, 1994
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 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)
  • K950788 — OTOSCOPE A-34 (May 3, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)

FDA data resources