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FDA 510(k)

Purema H Hemoconcentrator - Pediatric

K-Number: K243920 · 2025-09-19

ApplicantMedica USA, Inc.
Decision Date2025-09-19
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Purema H Hemoconcentrator - Pediatric is a medical device manufactured by Medica USA, Inc.. It received FDA 510(k) clearance on 2025-09-19 under approval number K243920. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Purema H Hemoconcentrator - Pediatric?

Purema H Hemoconcentrator - Pediatric is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Medica USA, Inc.. The 510(k) number is K243920.

When was Purema H Hemoconcentrator - Pediatric approved by the FDA?

Purema H Hemoconcentrator - Pediatric received FDA 510(k) clearance on 2025-09-19, under approval number K243920.

What company makes Purema H Hemoconcentrator - Pediatric?

Purema H Hemoconcentrator - Pediatric is manufactured by Medica USA, Inc..

What is the FDA product code for Purema H Hemoconcentrator - Pediatric?

The FDA product code for Purema H Hemoconcentrator - Pediatric is KDI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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