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510(k) K884933

ENDOSTROBOSCOPE IV by Jedmed Instrument Co. — Product Code EQL

K884933 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "ENDOSTROBOSCOPE IV". The FDA issued a decision of Substantially Equivalent on February 15, 1989. The device falls under product code EQL (Laryngostroboscope), a Class I device regulated under 21 CFR 874.4750. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1989
Date Received
November 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngostroboscope
Device Class
Class I
Regulation Number
874.4750
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)
  • K950925 — JEDMED LARYNGEAL SCOPE (August 11, 1995)
  • K953457 — JEDMED SPECTRUM ENT CABINET (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 EQL

  • K984521 — RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 (March 17, 1999)
  • K921184 — RLS 9100 RHINO-LARYNGEAL STROBOSCOPE (May 28, 1992)
  • K921285 — 9105 RIGID TELESCOPIC ENDOSCOPE (May 28, 1992)
  • K842090 — RHINO-LARYNX STROBOSCOPE TYPE 4914 (July 18, 1984)
  • K822523 — LARYNGOSTROBOSCOPE (September 9, 1982)
  • K801866 — PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A (September 16, 1980)
  • K770466 — STOCKINGS, RVS TM (March 28, 1977)

FDA data resources