510(k) K831255

LARYNGOSCOPE ATTACHMENT PH2000 by Eder Instrument Co, Inc. — Product Code EQN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 12, 1983
Date Received: April 18, 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 Eder Instrument Co, Inc.

K843498 — BIPOLAR SUCTION ELECTRODE (December 14, 1984)
K843499 — ARTHROSCOPY LEG HOLDER (October 31, 1984)
K843497 — SURGICAL KNIVES & PROBES (October 31, 1984)
K831240 — LASER BRONCHOSCOPE (July 26, 1983)
K831241 — LASER LAPARAXOPE (June 10, 1983)
K822959 — ENDOSCOPIC VIDEOSYSTEM (October 22, 1982)
K802479 — SURGICAL KNIVES & PROBES (October 31, 1980)
K792100 — GRASPING FORCEP (W/FOUR PRONGS) (November 13, 1979)
K791052 — ENDOSCOPIC INSTRUMENT (August 3, 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)
K830888 — COOL-LITE FIBERCOPTIC LARYNGEAL EXAM (April 27, 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)