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510(k) K921848

BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT by Alm Surgical Equipment, Inc. — Product Code FSQ

K921848 is an FDA 510(k) premarket notification submitted by Alm Surgical Equipment, Inc. for the device "BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT". The FDA issued a decision of Substantially Equivalent on October 1, 1992. The device falls under product code FSQ (Light, Surgical, Instrument), a Class II device regulated under 21 CFR 878.4580. Alm Surgical Equipment, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1992
Date Received
April 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Alm Surgical Equipment, Inc.

  • K982063 — ALM PRISMALIX (PRX) SURGICAL LIGHT (September 22, 1998)
  • 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)
  • K884019 — ALM OPERATING TABLES (October 13, 1988)
  • K882613 — ALM SURGICAL LAMPS (July 18, 1988)

Other clearances for product code FSQ

  • K932139 — LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT (July 30, 1993)
  • K930686 — MIDMARK SURGICAL LIGHTING SYSTEMS (July 30, 1993)
  • K922409 — ALM ILLUMINATOR SERIES LIGHT SYSTEM (January 12, 1993)
  • K803067 — SURG-FLEX 10 LIGHT (February 26, 1981)
  • K810019 — SURG-FLEX 15 SURGICAL LIGHT (January 23, 1981)
  • K810018 — SURG-FLEX 5 SURGICAL LIGHT (January 23, 1981)

FDA data resources