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510(k) K843559

KLEENIT BY QMED by Qmed, Inc.

K843559 is an FDA 510(k) premarket notification submitted by Qmed, Inc. for the device "KLEENIT BY QMED". The FDA issued a decision of Substantially Equivalent on October 24, 1984. Qmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1984
Date Received
September 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Qmed, Inc.

  • K972991 — MONITOR ONE NDX (December 3, 1998)
  • K932109 — PROFILOMAT (December 3, 1993)
  • K921476 — INTERP-1000 (October 21, 1992)
  • K897121 — QEKG ELECTROCARDIOGRAPH (April 30, 1990)
  • K873591 — A.R.M. (ASPEN RETURN MONITOR) (September 30, 1987)
  • K862377 — QMED SELF ADHERING ELECTRODE (September 26, 1986)
  • K863091 — BICORD BY QMED (August 29, 1986)
  • K861437 — QMED SYSTEM 2150 (May 20, 1986)
  • K841172 — MONITOR ONE (July 27, 1984)
  • K840465 — Q-MED ELECTRODE (June 19, 1984)

FDA data resources