Home / 510(k) Clearances / K964406

510(k) K964406

AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER by Daxor Corporation — Product Code JWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1997
Date Received
November 4, 1996
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

  • K251087 — Blood Volume Analyzer (200) (August 4, 2025)
  • K970419 — DAXOR MAX100 SYRINGE (MAX100) (December 22, 1997)

Other clearances for product code JWO

  • K251087 — Blood Volume Analyzer (200) (August 4, 2025)