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510(k) K031964

BPCARD by Qrs Diagnostic, LLC — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2003
Date Received
June 25, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
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)
  • 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)

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