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510(k) K030535

EKGCARD SYSTEM by Qrs Diagnostic, LLC — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2003
Date Received
February 20, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Qrs Diagnostic, LLC

  • K083749 — CARDIOVIEW32 REVIEW MODULE (March 10, 2009)
  • K073630 — MODIFICATION TO: BPCARD, MODEL Z-7000-0700 (January 11, 2008)
  • K031964 — BPCARD (September 5, 2003)
  • K001278 — SENSAIRE DIAGNOSTIC SPIROMETER (November 29, 2000)
  • K001995 — SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER (September 8, 2000)
  • K973138 — SPIROCARD (October 28, 1998)

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