510(k) K821182

MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- by Machida America, Inc. — Product Code EQN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 13, 1982
Date Received: April 27, 1982
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)
K821181 — FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # (May 13, 1982)
K812734 — MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P (October 19, 1981)
K811943 — MACHIDA NASOPHARYNGO-LARYNGOSCOPE (July 28, 1981)

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)
K830888 — COOL-LITE FIBERCOPTIC LARYNGEAL EXAM (April 27, 1983)
K822525 — LARYNGOSCOPES RIGID (September 9, 1982)
K821709 — NAGASHIMA LIGHT SOURCE UNIT SL-5 (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)