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510(k) K904118

SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST. by Dawn Medical — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1991
Date Received
September 6, 1990
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

Other clearances by Dawn Medical

  • K933135 — DAWN DISPOSABLE BIOPSY FORCEPS (March 7, 1994)
  • K904117 — SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. (February 25, 1991)
  • K905733 — SEROMA-CATH CLOSE DRAINAGE SYSTEM (January 28, 1991)

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