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FDA 510(k)

AT

K-Nummer: K212645 · 2021-12-16

AntragstellerAt Glove Engineering Sdn. Bhd
Entscheidungsdatum2021-12-16
ProduktcodeLZA
BeratungsausschussHO
EntscheidungSubstantially Equivalent

Produktübersicht

AT is the device name listed in this FDA 510(k) record. The listed applicant is At Glove Engineering Sdn. Bhd. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K212645. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the AT?

AT is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is At Glove Engineering Sdn. Bhd. The 510(k) number is K212645.

When did AT receive FDA 510(k) clearance?

AT received FDA 510(k) clearance on 2021-12-16, under 510(k) number K212645.

Who is the listed applicant for AT?

The FDA 510(k) record lists At Glove Engineering Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AT?

The FDA product code for AT is LZA.

Zugehörige PubMed-Literatur

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PMID: 42834824India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.Expert review of medical devices ()PMID: 42825233Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.Neurosurgery practice ()PMID: 42815842Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.Regulatory toxicology and pharmacology : RTP ()PMID: 42749521Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.Clinical therapeutics ()

Verwandte Geräte (Code: LZA)

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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