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FDA 510(k)

SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4

K-Number: K904965 · 1991-01-16

ApplicantSmith & Nephew Equipment Group
Decision Date1991-01-16
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Equipment Group. It received FDA 510(k) clearance on 1991-01-16 under 510(k) number K904965. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4?

SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 is a medical device that received FDA 510(k) clearance on 1991-01-16. The listed applicant is Smith & Nephew Equipment Group. The 510(k) number is K904965.

When did SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 receive FDA 510(k) clearance?

SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 received FDA 510(k) clearance on 1991-01-16, under 510(k) number K904965.

Who is the listed applicant for SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4?

The FDA 510(k) record lists Smith & Nephew Equipment Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4?

The FDA product code for SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 is FSY.

Related Clinical Trials

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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Other records listing Smith & Nephew Equipment Group 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.

K910783SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M

Related Devices (Code: FSY)

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.

K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker CommunicationsK132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems CorporationK131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.K122875ORICARE L2700Oricare, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGK102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

Official Source

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