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510(k) K073630

MODIFICATION TO: BPCARD, MODEL Z-7000-0700 by Qrs Diagnostic, LLC — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2008
Date Received
December 26, 2007
Clearance Type
Special
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)
  • 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)

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