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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 the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Limited. It received FDA 510(k) clearance on 2025-12-16 under 510(k) 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. The listed applicant is Skanray Technologies Limited. The 510(k) number is K251893.

When did SKAN C PULSAR receive FDA 510(k) clearance?

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

Who is the listed applicant for SKAN C PULSAR?

The FDA 510(k) record lists Skanray Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKAN C PULSAR?

The FDA product code for SKAN C PULSAR is OWB.

Other records listing Skanray Technologies Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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