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FDA 510(k)

GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT

K-Number: K974084 · 1998-03-03

ApplicantGetinge/Castle, Inc.
Decision Date1998-03-03
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Getinge/Castle, Inc.. It received FDA 510(k) clearance on 1998-03-03 under 510(k) number K974084. 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 GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT?

GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT is a medical device that received FDA 510(k) clearance on 1998-03-03. The listed applicant is Getinge/Castle, Inc.. The 510(k) number is K974084.

When did GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT receive FDA 510(k) clearance?

GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT received FDA 510(k) clearance on 1998-03-03, under 510(k) number K974084.

Who is the listed applicant for GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT?

The FDA 510(k) record lists Getinge/Castle, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT?

The FDA product code for GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT is FSY.

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Other records listing Getinge/Castle, Inc. 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.

K020205CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KITK020590MODEL 733HC GRAVITY/VACUUM STEAM STERILIZERK012573CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HCK003441CASTLE MODEL 233HC STEAM STERILIZERK994314CASTLE SERIES 100HC STEAM STERILIZERSK993242CASTLE SURGICAL LIGHT, MODEL 3000

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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

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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