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510(k) K864325

DR7700 OPERATING TABLE by Koken Mfg Company, Inc. — Product Code FQO

K864325 is an FDA 510(k) premarket notification submitted by Koken Mfg Company, Inc. for the device "DR7700 OPERATING TABLE". The FDA issued a decision of Substantially Equivalent on November 19, 1986. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Koken Mfg Company, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1986
Date Received
November 3, 1986
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 Koken Mfg Company, Inc.

  • K864501 — KOKEN'S NEW MODEL M-3000 POWER TABLE (December 16, 1986)
  • K864494 — MODEL 6500 OPTHALMIC CHAIR (December 15, 1986)
  • K864574 — MAC 150E OPTHALMIC CHAIR (December 15, 1986)
  • K864295 — DR.500O OPERATING TABLE (November 19, 1986)

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