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510(k) K921476

INTERP-1000 by Qmed, Inc. — Product Code LOS

K921476 is an FDA 510(k) premarket notification submitted by Qmed, Inc. for the device "INTERP-1000". The FDA issued a decision of Substantially Equivalent on October 21, 1992. Qmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1992
Date Received
March 30, 1992
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)
  • 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)
  • K843559 — KLEENIT BY QMED (October 24, 1984)
  • K841172 — MONITOR ONE (July 27, 1984)
  • K840465 — Q-MED ELECTRODE (June 19, 1984)

Other clearances for product code LOS

  • K090895 — EKG-PLUS II SOFTWARE (August 26, 2009)
  • K083749 — CARDIOVIEW32 REVIEW MODULE (March 10, 2009)
  • K073376 — PHILIPS ECG ALGORITHM (April 11, 2008)
  • K023034 — CARDIOTOUCH-3000 (November 14, 2002)
  • K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (November 21, 2001)
  • K993616 — CARDIO-CARD INTERPRETATION SYSTEM I (April 10, 2000)
  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
  • K991014 — CASE 8000 EXERCISE TESTING SYSTEM (October 20, 1999)
  • K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (August 19, 1999)
  • K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (April 16, 1999)

FDA data resources