Home / 510(k) Clearances / K003665

510(k) K003665

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2001
Date Received
November 28, 2000
Clearance Type
Traditional
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.

  • K011874 — FADASIS MEDICAL FM-1 NO BLENDER (July 20, 2001)

Other clearances for product code MRO

  • K122689 — INOBLENDER (November 7, 2012)
  • K052663 — INO THERAPEUTICS INOBLENDER, MODEL 10004 (November 4, 2005)
  • K011874 — FADASIS MEDICAL FM-1 NO BLENDER (July 20, 2001)