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510(k) K011874

FADASIS MEDICAL FM-1 NO BLENDER by Fadasis Medical, Inc. — Product Code MRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2001
Date Received
June 15, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Nitric Oxide, Backup Delivery
Device Class
Class II
Regulation Number
868.5165
Review Panel
AN
Submission Type

Other clearances by Fadasis Medical, Inc.

  • K003665 — FADASSI MEDICAL FM-1 NO BLENDER (February 23, 2001)

Other clearances for product code MRO

  • K122689 — INOBLENDER (November 7, 2012)
  • K052663 — INO THERAPEUTICS INOBLENDER, MODEL 10004 (November 4, 2005)
  • K003665 — FADASSI MEDICAL FM-1 NO BLENDER (February 23, 2001)