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510(k) K840027

OPERATING ROOM STAND by Healthmate, Inc. — Product Code FSE

K840027 is an FDA 510(k) premarket notification submitted by Healthmate, Inc. for the device "OPERATING ROOM STAND". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Healthmate, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
January 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Manual
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

Other clearances by Healthmate, Inc.

  • K854162 — SUPPORT ARM (December 9, 1985)
  • K843920 — FLUOROSCAN/TM BY HEALTHMATE (February 7, 1985)

Other clearances for product code FSE

  • K860503 — THE POREX RETRACTOR TABLE (March 13, 1986)
  • K843801 — MASON EQUIPMENT ORGANIZER & ASPEN (October 25, 1984)
  • K831042 — CHEMONUCLEOLYSIS TABLE EXTENSION (May 16, 1983)
  • K830339 — IMSI/METRIPOND HAND OPERATING TABLE (April 12, 1983)
  • K822427 — SELF-CONTAINED MOBILE OPHTHAL. OPER. . (September 14, 1982)
  • K821924 — TABLE, OPERATING, FIELD 6530-00-709-8155 (July 13, 1982)
  • K801382 — DISPOSABLE SURGICAL HEAD SUPPORT (June 26, 1980)
  • K782092 — ARMBOARD CVER, DISPOSABLE (January 10, 1979)
  • K780868 — CHEST ROLLS (August 14, 1978)
  • K780867 — PAD HOLDER KIT (August 14, 1978)

FDA data resources