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510(k) K811943

MACHIDA NASOPHARYNGO-LARYNGOSCOPE by Machida America, Inc. — Product Code EQN

K811943 is an FDA 510(k) premarket notification submitted by Machida America, Inc. for the device "MACHIDA NASOPHARYNGO-LARYNGOSCOPE". The FDA issued a decision of Substantially Equivalent on July 28, 1981. The device falls under product code EQN (Laryngoscope, Nasopharyngoscope), a Class II device regulated under 21 CFR 874.4760. Machida America, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
July 7, 1981
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 Machida America, Inc.

  • K871712 — MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. (January 14, 1988)
  • K854581 — MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 (February 28, 1986)
  • K844834 — MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1 (June 11, 1985)
  • K841087 — FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 (May 16, 1984)
  • K821182 — MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- (May 13, 1982)
  • K821181 — FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # (May 13, 1982)
  • K812734 — MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P (October 19, 1981)

Other clearances for product code EQN

  • K252624 — KARL STORZ Laryngoscopes and Accessories (May 15, 2026)
  • 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)
  • K830888 — COOL-LITE FIBERCOPTIC LARYNGEAL EXAM (April 27, 1983)
  • K822525 — LARYNGOSCOPES RIGID (September 9, 1982)
  • K821707 — NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT (June 25, 1982)
  • K821706 — NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL (June 25, 1982)
  • K821709 — NAGASHIMA LIGHT SOURCE UNIT SL-5 (June 25, 1982)

FDA data resources