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510(k) K942043

DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E by Alm Surgical Equipment, Inc. — Product Code FQO

K942043 is an FDA 510(k) premarket notification submitted by Alm Surgical Equipment, Inc. for the device "DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E". The FDA issued a decision of Substantially Equivalent on July 13, 1994. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Alm Surgical Equipment, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1994
Date Received
April 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
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)
  • 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 FQO

  • K240598 — Maestro System (REF100) (June 3, 2024)
  • K221410 — Maestro Platform (December 2, 2022)
  • K090136 — STERIS CMAX XLT SURGICAL TABLE (March 20, 2009)
  • K972810 — OPT80 THE TRANSPORTABLE (OPT80) (August 26, 1997)
  • K971988 — ALLEN, ULTRA AND SMART SOCKETS (July 11, 1997)
  • K971307 — AMSCO SURGICAL TABLE (June 27, 1997)
  • K963506 — TENET RADIOLUCENT HAND TABLE (January 9, 1997)
  • 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)
  • K955750 — TELETOM (February 8, 1996)

FDA data resources