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FDA 510(k)

SKAN C PULSAR

K-Number: K251893 · 2025-12-16

ApplicantSkanray Technologies Limited
Decision Date2025-12-16
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SKAN C PULSAR is a medical device manufactured by Skanray Technologies Limited. It received FDA 510(k) clearance on 2025-12-16 under approval number K251893. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKAN C PULSAR?

SKAN C PULSAR is a medical device that received FDA 510(k) clearance on 2025-12-16. It is manufactured by Skanray Technologies Limited. The 510(k) number is K251893.

When was SKAN C PULSAR approved by the FDA?

SKAN C PULSAR received FDA 510(k) clearance on 2025-12-16, under approval number K251893.

What company makes SKAN C PULSAR?

SKAN C PULSAR is manufactured by Skanray Technologies Limited.

What is the FDA product code for SKAN C PULSAR?

The FDA product code for SKAN C PULSAR is OWB.

Other Devices by Skanray Technologies Limited

K220518SKANRAD 400 K212940Skanmobile, Skanmobile-Dr K231761PodSKAN HF Diagnostic X-ray System

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Official Source

View on FDA Database →

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

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