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510(k) K943731

VIDEO OTOSCOPE by Cuda Products Co. — Product Code ERA

K943731 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "VIDEO OTOSCOPE". The FDA issued a decision of Substantially Equivalent on October 11, 1994. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Cuda Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1994
Date Received
August 2, 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 Cuda Products Co.

  • K983277 — LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (December 16, 1998)
  • K981962 — CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (August 18, 1998)
  • K981469 — CERMAX300 LIGHTSOURCE (July 9, 1998)
  • K980350 — VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 (April 28, 1998)
  • K980166 — LIGHTSOURCE OR ILLUMINATOR (April 1, 1998)
  • K961074 — LIGHTSOURCE OR ILLUMINATOR (April 30, 1996)
  • K951019 — INTRAORAL VIDEO SCOPE AND WINDOW TUBE (May 10, 1995)
  • K935818 — ENDOSCOPE (July 13, 1994)
  • K933369 — CUDA PRODUCTS CORP. LIGHTSOURCES (January 3, 1994)
  • K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (November 18, 1993)

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