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FDA 510(k)

Neurophet SCALE PET

K-Number: K221405 · 2022-08-05

ApplicantNeurophet., Inc.
Decision Date2022-08-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Neurophet SCALE PET is a medical device manufactured by Neurophet., Inc.. It received FDA 510(k) clearance on 2022-08-05 under approval number K221405. 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 Neurophet SCALE PET?

Neurophet SCALE PET is a medical device that received FDA 510(k) clearance on 2022-08-05. It is manufactured by Neurophet., Inc.. The 510(k) number is K221405.

When was Neurophet SCALE PET approved by the FDA?

Neurophet SCALE PET received FDA 510(k) clearance on 2022-08-05, under approval number K221405.

What company makes Neurophet SCALE PET?

Neurophet SCALE PET is manufactured by Neurophet., Inc..

What is the FDA product code for Neurophet SCALE PET?

The FDA product code for Neurophet SCALE PET is LLZ.

Other Devices by Neurophet., Inc.

K220437Neurophet AQUA K242215Neurophet AQUA (V3.1) K252563Neurophet SCALE PET K261273Neurophet AQUA K252496Neurophet AQUA AD Plus

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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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