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FDA 510(k)

LIGHTSOURCE OR ILLUMINATOR MODEL I-100

K-Number: K983277 · 1998-12-16

ApplicantCuda Products Co.
Decision Date1998-12-16
Product CodeHBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHTSOURCE OR ILLUMINATOR MODEL I-100 is the device name listed in this FDA 510(k) record. The listed applicant is Cuda Products Co.. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K983277. The device is classified under product code HBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHTSOURCE OR ILLUMINATOR MODEL I-100?

LIGHTSOURCE OR ILLUMINATOR MODEL I-100 is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Cuda Products Co.. The 510(k) number is K983277.

When did LIGHTSOURCE OR ILLUMINATOR MODEL I-100 receive FDA 510(k) clearance?

LIGHTSOURCE OR ILLUMINATOR MODEL I-100 received FDA 510(k) clearance on 1998-12-16, under 510(k) number K983277.

Who is the listed applicant for LIGHTSOURCE OR ILLUMINATOR MODEL I-100?

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

What is the FDA product code for LIGHTSOURCE OR ILLUMINATOR MODEL I-100?

The FDA product code for LIGHTSOURCE OR ILLUMINATOR MODEL I-100 is HBI.

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Other records listing Cuda Products 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.

K981962CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCEK981469CERMAX300 LIGHTSOURCEK980350VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150K980166LIGHTSOURCE OR ILLUMINATORK961074LIGHTSOURCE OR ILLUMINATORK951019INTRAORAL VIDEO SCOPE AND WINDOW TUBE

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Related Devices (Code: HBI)

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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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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