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FDA 510(k)

Blood Volume Analyzer (200)

K-Number: K251087 · 2025-08-04

Decision Date2025-08-04
Product CodeJWO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Blood Volume Analyzer (200) is a medical device manufactured by Daxor Corporation. It received FDA 510(k) clearance on 2025-08-04 under approval number K251087. The device is classified under product code JWO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blood Volume Analyzer (200)?

Blood Volume Analyzer (200) is a medical device that received FDA 510(k) clearance on 2025-08-04. It is manufactured by Daxor Corporation. The 510(k) number is K251087.

When was Blood Volume Analyzer (200) approved by the FDA?

Blood Volume Analyzer (200) received FDA 510(k) clearance on 2025-08-04, under approval number K251087.

What company makes Blood Volume Analyzer (200)?

Blood Volume Analyzer (200) is manufactured by Daxor Corporation.

What is the FDA product code for Blood Volume Analyzer (200)?

The FDA product code for Blood Volume Analyzer (200) is JWO.

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Official Source

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