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510(k) K032755

MODEL 509M PULSE OXIMETER, MODEL 509M by Respironics Novametrix, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2004
Date Received
September 5, 2003
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

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  • K032971 — TIDAL WAVE SP MODEL 710/715 AND 715 (August 26, 2004)
  • K032949 — SPOT CHECK PULSE OXIMETER,512/513 (August 23, 2004)
  • K041450 — MODIFICATION TO NICO WITH MARS, MODEL 7300 (June 18, 2004)
  • K030886 — NICO WITH MARS, MODEL 7300 (October 7, 2003)

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