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510(k) K811915

MONITOR/VITAL SIGNS TRAY by American Hospital Supply Corp. — Product Code FME

K811915 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "MONITOR/VITAL SIGNS TRAY". The FDA issued a decision of Substantially Equivalent on July 28, 1981. The device falls under product code FME (Gown, Examination), a Class I device regulated under 21 CFR 880.6265. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
July 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Examination
Device Class
Class I
Regulation Number
880.6265
Review Panel
HO
Submission Type

Other clearances by American Hospital Supply Corp.

  • K854739 — AMERICAN STERILE SURGICAL ABSORBENT TOWEL (December 27, 1985)
  • K854759 — AMERICAN STERILE MAYO STAND TRAY (December 17, 1985)
  • K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS (April 23, 1984)
  • K830546 — DOSIMETRIC RELEASE (May 25, 1983)
  • K822990 — CONVERTORS PRIMARY WOUND DRESSING II (April 12, 1983)
  • K830343 — CONTAINER W/PRIMING SOLUTION (March 17, 1983)
  • K830301 — STRATUS FLUOROMETRIC ENZYME IMMUN0- (February 25, 1983)
  • K822755 — LATEX PENROSE TUBING (January 21, 1983)
  • K823418 — HEYER-SCHUTE UNIVERSAL URETERAL STENT (December 3, 1982)
  • K822966 — CONVERTORS DISPOSABLE DRESSING SPONGE (November 5, 1982)

Other clearances for product code FME

  • K880385 — KIMBERLY-CLARK PROFESSIONAL JACKET (February 19, 1988)
  • K770476 — EXAM GOWN (May 6, 1977)
  • K760954 — CROWNTEX EXAM. CAPE & GOWN (December 30, 1976)
  • K760360 — SHIRT, MITTEN CUFF INFANT (October 20, 1976)

FDA data resources