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510(k) K924025

OTO-BRITE HANDLE by Jedmed Instrument Co. — Product Code ERA

K924025 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "OTO-BRITE HANDLE". The FDA issued a decision of Substantially Equivalent on November 6, 1992. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1992
Date Received
August 11, 1992
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 Jedmed Instrument Co.

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
  • K021750 — LID CHAIN EYELID WEIGHTS (January 27, 2003)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K944032 — VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (September 15, 1995)
  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K950925 — JEDMED LARYNGEAL SCOPE (August 11, 1995)
  • K950785 — HORTMANN AIRMATIC AIR CALORIC STIMULATOR (June 28, 1995)
  • K950078 — MICROFLOW IRRIGATION SYSTEM (June 21, 1995)
  • K944671 — VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) (February 7, 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)
  • K950788 — OTOSCOPE A-34 (May 3, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)

FDA data resources