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FDA 510(k)

PREMIO 10 MOXA

K-Number: K101267 · 2010-12-03

ApplicantSedatelec
Decision Date2010-12-03
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PREMIO 10 MOXA is the device name listed in this FDA 510(k) record. The listed applicant is Sedatelec. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K101267. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIO 10 MOXA?

PREMIO 10 MOXA is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Sedatelec. The 510(k) number is K101267.

When did PREMIO 10 MOXA receive FDA 510(k) clearance?

PREMIO 10 MOXA received FDA 510(k) clearance on 2010-12-03, under 510(k) number K101267.

Who is the listed applicant for PREMIO 10 MOXA?

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

What is the FDA product code for PREMIO 10 MOXA?

The FDA product code for PREMIO 10 MOXA is ILY.

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Other records listing Sedatelec 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.

K060392ASP TITANIUMK983800DN ACUPUNTURE NEEDLESK983798SEDATELEC ASP ACUPUNCTURE NEEDLES

Related Devices (Code: ILY)

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.

K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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