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510(k) K080391

DRIVE SOLSTICE OXYGEN CONCENTRATOR by Medical Depot — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2008
Date Received
February 13, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

Other clearances by Medical Depot

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  • K003344 — MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 (March 15, 2001)
  • K003783 — MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER (January 12, 2001)

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