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510(k) K911901

MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE by Stortz — Product Code ETF

K911901 is an FDA 510(k) premarket notification submitted by Stortz for the device "MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on July 26, 1991. 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
July 26, 1991
Date Received
April 29, 1991
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

Other clearances for product code ETF

  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K945395 — PREMIER MIRROR WARMER (January 18, 1995)
  • K932470 — LANGGASSE 90 (August 25, 1993)
  • 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