Home / 510(k) Clearances / K261099

510(k) K261099

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
April 2, 2026
Clearance Type
Special
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

  • K251087 — Blood Volume Analyzer (200) (August 4, 2025)
  • K970419 — DAXOR MAX100 SYRINGE (MAX100) (December 22, 1997)
  • K964406 — AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER (September 25, 1997)

Other clearances for product code JWO

  • K251087 — Blood Volume Analyzer (200) (August 4, 2025)
  • K964406 — AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER (September 25, 1997)