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FDA 510(k)

Aerus Medical Guardian,model F170A

K-Number: K201220 · 2020-06-17

ApplicantAerus Medical, LLC
Decision Date2020-06-17
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Aerus Medical Guardian,model F170A is a medical device manufactured by Aerus Medical, LLC. It received FDA 510(k) clearance on 2020-06-17 under approval number K201220. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aerus Medical Guardian,model F170A?

Aerus Medical Guardian,model F170A is a medical device that received FDA 510(k) clearance on 2020-06-17. It is manufactured by Aerus Medical, LLC. The 510(k) number is K201220.

When was Aerus Medical Guardian,model F170A approved by the FDA?

Aerus Medical Guardian,model F170A received FDA 510(k) clearance on 2020-06-17, under approval number K201220.

What company makes Aerus Medical Guardian,model F170A?

Aerus Medical Guardian,model F170A is manufactured by Aerus Medical, LLC.

What is the FDA product code for Aerus Medical Guardian,model F170A?

The FDA product code for Aerus Medical Guardian,model F170A is FRA.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

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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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