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FDA 510(k)

SDL-300

K-Number: K854337 · 1986-06-20

ApplicantShimadzu Corp.
Decision Date1986-06-20
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SDL-300 is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 1986-06-20 under 510(k) number K854337. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDL-300?

SDL-300 is a medical device that received FDA 510(k) clearance on 1986-06-20. The listed applicant is Shimadzu Corp.. The 510(k) number is K854337.

When did SDL-300 receive FDA 510(k) clearance?

SDL-300 received FDA 510(k) clearance on 1986-06-20, under 510(k) number K854337.

Who is the listed applicant for SDL-300?

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

What is the FDA product code for SDL-300?

The FDA product code for SDL-300 is ITX.

Other records listing Shimadzu Corp. 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.

K101039SHIMADZU COLLIMATOR R-300K101036SHIMADZU COLLIMATOR R-20JK090578SHIMADZU COLLIMATOR R-30HK090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONK080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONK072006DAR-9400F

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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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