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510(k) K830888

COOL-LITE FIBERCOPTIC LARYNGEAL EXAM by National Medical Technology — Product Code EQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1983
Date Received
March 21, 1983
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 National Medical Technology

  • K871668 — BIODAN TYPE COMET ELECTRODE (June 10, 1987)
  • K861158 — S&W TYPE 888 ELECTRODE (July 1, 1986)
  • K790845 — DUALUME LARYNGEAL EXAMINATION TELESCOPE (July 24, 1979)

Other clearances for product code EQN

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
  • K834172 — OP-CON SURG. INSTRUMENT #7 (March 6, 1984)
  • K831255 — LARYNGOSCOPE ATTACHMENT PH2000 (September 12, 1983)
  • K822525 — LARYNGOSCOPES RIGID (September 9, 1982)
  • K821706 — NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL (June 25, 1982)
  • K821707 — NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT (June 25, 1982)
  • K821710 — NAGASHIMA NX-150F LIGHT SOURCE UNIT (June 25, 1982)
  • K821708 — NAGASHIMA LIGHT SOURCE UNIT SL-4 (June 25, 1982)
  • K821709 — NAGASHIMA LIGHT SOURCE UNIT SL-5 (June 25, 1982)