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510(k) K001278

SENSAIRE DIAGNOSTIC SPIROMETER by Qrs Diagnostic, LLC — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2000
Date Received
April 21, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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  • K001995 — SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER (September 8, 2000)
  • K973138 — SPIROCARD (October 28, 1998)

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