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510(k) K132039

ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM by Jedmed Instrument Co. — Product Code EQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2014
Date Received
July 2, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Nasopharyngoscope
Device Class
Class II
Regulation Number
874.4760
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Jedmed Instrument Co.

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • 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)
  • K944031 — VIDEO SCOPE SYSTEM (OTOSCOPE) (September 23, 1994)

Other clearances for product code EQN

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K834172 — OP-CON SURG. INSTRUMENT #7 (March 6, 1984)
  • K831255 — LARYNGOSCOPE ATTACHMENT PH2000 (September 12, 1983)
  • K830888 — COOL-LITE FIBERCOPTIC LARYNGEAL EXAM (April 27, 1983)
  • K822525 — LARYNGOSCOPES RIGID (September 9, 1982)
  • K821710 — NAGASHIMA NX-150F LIGHT SOURCE UNIT (June 25, 1982)
  • K821707 — NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT (June 25, 1982)
  • K821706 — NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL (June 25, 1982)
  • K821708 — NAGASHIMA LIGHT SOURCE UNIT SL-4 (June 25, 1982)
  • K821709 — NAGASHIMA LIGHT SOURCE UNIT SL-5 (June 25, 1982)