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510(k) K083749

CARDIOVIEW32 REVIEW MODULE by Qrs Diagnostic, LLC — Product Code LOS

K083749 is an FDA 510(k) premarket notification submitted by Qrs Diagnostic, LLC for the device "CARDIOVIEW32 REVIEW MODULE". The FDA issued a decision of Substantially Equivalent on March 10, 2009. Qrs Diagnostic, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2009
Date Received
December 17, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Other clearances by Qrs Diagnostic, LLC

  • K073630 — MODIFICATION TO: BPCARD, MODEL Z-7000-0700 (January 11, 2008)
  • K031964 — BPCARD (September 5, 2003)
  • K030535 — EKGCARD SYSTEM (June 11, 2003)
  • K001278 — SENSAIRE DIAGNOSTIC SPIROMETER (November 29, 2000)
  • K001995 — SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER (September 8, 2000)
  • K973138 — SPIROCARD (October 28, 1998)

Other clearances for product code LOS

  • K090895 — EKG-PLUS II SOFTWARE (August 26, 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)
  • K984504 — NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES (April 15, 1999)

FDA data resources