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510(k) K001995

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER by Qrs Diagnostic, LLC — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2000
Date Received
June 30, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
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)
  • K030535 — EKGCARD SYSTEM (June 11, 2003)
  • K001278 — SENSAIRE DIAGNOSTIC SPIROMETER (November 29, 2000)
  • K973138 — SPIROCARD (October 28, 1998)

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