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510(k) K001708

PROFOX SOFTWARE, MODEL 920M-41 by Respironics Georgia, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2001
Date Received
June 5, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Respironics Georgia, Inc.

  • K011597 — SMARTMONITOR 2, MODEL 4000 (January 11, 2002)

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