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510(k) K932470

LANGGASSE 90 by Happersberger Otopront GmbH — Product Code ETF

K932470 is an FDA 510(k) premarket notification submitted by Happersberger Otopront GmbH for the device "LANGGASSE 90". The FDA issued a decision of Substantially Equivalent on August 25, 1993. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1993
Date Received
May 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Examining/Treatment, Ent
Device Class
Class I
Regulation Number
874.5300
Review Panel
EN
Submission Type

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  • K945395 — PREMIER MIRROR WARMER (January 18, 1995)
  • K911901 — MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE (July 26, 1991)
  • K910781 — #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES (May 15, 1991)
  • K910243 — MOBILE TREATMENT CART (April 17, 1991)
  • K896298 — JEDMED S CHAIR (January 26, 1990)
  • K896273 — SYSTEMA ENT CABINET (January 26, 1990)
  • K881958 — JEDMED MAXIM ENT CABINET (July 15, 1988)
  • K860940 — MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT (May 2, 1986)
  • K855021 — LARYNGEAL MIRROR PRE-WARMER (March 20, 1986)

FDA data resources