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FDA 510(k)

9100 DAYSTAR AND 9110 ORBITER PACKAGE

K-Number: K781887 · 1978-12-12

ApplicantCastle Co.
Decision Date1978-12-12
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

9100 DAYSTAR AND 9110 ORBITER PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Castle Co.. It received FDA 510(k) clearance on 1978-12-12 under 510(k) number K781887. 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 9100 DAYSTAR AND 9110 ORBITER PACKAGE?

9100 DAYSTAR AND 9110 ORBITER PACKAGE is a medical device that received FDA 510(k) clearance on 1978-12-12. The listed applicant is Castle Co.. The 510(k) number is K781887.

When did 9100 DAYSTAR AND 9110 ORBITER PACKAGE receive FDA 510(k) clearance?

9100 DAYSTAR AND 9110 ORBITER PACKAGE received FDA 510(k) clearance on 1978-12-12, under 510(k) number K781887.

Who is the listed applicant for 9100 DAYSTAR AND 9110 ORBITER PACKAGE?

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

What is the FDA product code for 9100 DAYSTAR AND 9110 ORBITER PACKAGE?

The FDA product code for 9100 DAYSTAR AND 9110 ORBITER PACKAGE is FSY.

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Other records listing Castle Co. 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.

K870975MODIFIED CASTLE POWERCLAVEK860263CASTLE 7538 FLOOR LOADING WASHERK844089CASTLE 7515 UTENSIL/GLASSWARE WASHERK834048BOVIE CONDUCTIVE ADHES-DISPER-ELECTROK833074CASTLE TEC-TEST S.M.A.R.T. PACKK831595CASTLE MODEL 3341 & 3441 & 4141 GAS AER

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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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