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510(k) K982063

ALM PRISMALIX (PRX) SURGICAL LIGHT by Alm Surgical Equipment, Inc. — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1998
Date Received
June 12, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Alm Surgical Equipment, Inc.

  • K961886 — DRAGER GEMINA WALL-MOUNTED WORKPLACE (July 30, 1996)
  • K961742 — DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (July 26, 1996)
  • K945102 — MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE (November 4, 1994)
  • K942043 — DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E (July 13, 1994)
  • K922409 — ALM ILLUMINATOR SERIES LIGHT SYSTEM (January 12, 1993)
  • K921297 — DRAGER DVE 4000 SERIES SYSTEM (November 27, 1992)
  • K921848 — BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT (October 1, 1992)
  • K884019 — ALM OPERATING TABLES (October 13, 1988)
  • K882613 — ALM SURGICAL LAMPS (July 18, 1988)

Other clearances for product code FSY

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  • K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT (September 30, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)