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FDA 510(k)

CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE

K-Number: K981962 · 1998-08-18

ApplicantCuda Products Co.
Decision Date1998-08-18
Product CodeFSS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE 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 1998-08-18 under 510(k) number K981962. The device is classified under product code FSS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE?

CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Cuda Products Co.. The 510(k) number is K981962.

When did CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE receive FDA 510(k) clearance?

CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE received FDA 510(k) clearance on 1998-08-18, under 510(k) number K981962.

Who is the listed applicant for CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE?

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 CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE?

The FDA product code for CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE is FSS.

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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.

K983277LIGHTSOURCE OR ILLUMINATOR MODEL I-100K981469CERMAX300 LIGHTSOURCEK980350VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150K980166LIGHTSOURCE OR ILLUMINATORK961074LIGHTSOURCE OR ILLUMINATORK951019INTRAORAL VIDEO SCOPE AND WINDOW TUBE

View all 17 devices →

Related Devices (Code: FSS)

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.

K091246ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)Trumpf Medizin Systeme GmbH + Co. KGK003489NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8Medical Illumination International, Inc.K984124AESCULAP XENON LIGHT SOURCEAesculap, Inc.K981821VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORAngiolaz, Inc.K981469CERMAX300 LIGHTSOURCECuda Products Co.K980044XENON 300MXPerkinelmer Optoelectronics

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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