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510(k) K941659

AURAL-CAM, VIDEO EAR, VID RX by Gracefully Yours, Inc. — Product Code ERA

K941659 is an FDA 510(k) premarket notification submitted by Gracefully Yours, Inc. for the device "AURAL-CAM, VIDEO EAR, VID RX". The FDA issued a decision of Substantially Equivalent on April 26, 1994. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Gracefully Yours, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1994
Date Received
April 5, 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 by Gracefully Yours, Inc.

  • K933633 — LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE (February 22, 1994)

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