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510(k) K031740

VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES by Welch Allyn Protocol, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2003
Date Received
June 4, 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

Other clearances by Welch Allyn Protocol, Inc.

  • K070204 — LINK TO ACUITY CLINICIAN NOTIFIER (March 23, 2007)
  • K063419 — MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) (December 4, 2006)
  • K033378 — VITAL SIGNS MONITOR, PROPAQ LT (March 1, 2004)
  • K022453 — MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM (August 21, 2002)
  • K021681 — MICROPAQ, MODELS 402, 404 (July 23, 2002)
  • K012451 — PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 (August 20, 2001)

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  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)