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510(k) K032809

HOSPITAL SPACER by Respironics Healthscan, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2003
Date Received
September 9, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Respironics Healthscan, Inc.

  • K013027 — MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 (December 6, 2001)

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