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FDA 510(k)

SubtleREFORMAT (1.x)

K-Number: K233699 · 2024-04-29

ApplicantSubtle Medical, Inc.
Decision Date2024-04-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SubtleREFORMAT (1.x) is the device name listed in this FDA 510(k) record. The listed applicant is Subtle Medical, Inc.. It received FDA 510(k) clearance on 2024-04-29 under 510(k) number K233699. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SubtleREFORMAT (1.x)?

SubtleREFORMAT (1.x) is a medical device that received FDA 510(k) clearance on 2024-04-29. The listed applicant is Subtle Medical, Inc.. The 510(k) number is K233699.

When did SubtleREFORMAT (1.x) receive FDA 510(k) clearance?

SubtleREFORMAT (1.x) received FDA 510(k) clearance on 2024-04-29, under 510(k) number K233699.

Who is the listed applicant for SubtleREFORMAT (1.x)?

The FDA 510(k) record lists Subtle Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SubtleREFORMAT (1.x)?

The FDA product code for SubtleREFORMAT (1.x) is LLZ.

Other records listing Subtle Medical, Inc. 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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Related Devices (Code: LLZ)

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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