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510(k) K251087

Blood Volume Analyzer (200) by Daxor Corporation — Product Code JWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2025
Date Received
April 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Blood Volume Measuring
Device Class
Class II
Regulation Number
864.5950
Review Panel
HE
Submission Type

Other clearances by Daxor Corporation

  • K970419 — DAXOR MAX100 SYRINGE (MAX100) (December 22, 1997)
  • K964406 — AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER (September 25, 1997)

Other clearances for product code JWO

  • K964406 — AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER (September 25, 1997)