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FDA 510(k)

PHOT-X II, MODEL 303

K-Number: K042260 · 2004-09-07

ApplicantTakara Belmont USA, Inc.
Decision Date2004-09-07
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHOT-X II, MODEL 303 is the device name listed in this FDA 510(k) record. The listed applicant is Takara Belmont USA, Inc.. It received FDA 510(k) clearance on 2004-09-07 under 510(k) number K042260. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOT-X II, MODEL 303?

PHOT-X II, MODEL 303 is a medical device that received FDA 510(k) clearance on 2004-09-07. The listed applicant is Takara Belmont USA, Inc.. The 510(k) number is K042260.

When did PHOT-X II, MODEL 303 receive FDA 510(k) clearance?

PHOT-X II, MODEL 303 received FDA 510(k) clearance on 2004-09-07, under 510(k) number K042260.

Who is the listed applicant for PHOT-X II, MODEL 303?

The FDA 510(k) record lists Takara Belmont USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOT-X II, MODEL 303?

The FDA product code for PHOT-X II, MODEL 303 is EHD.

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Other records listing Takara Belmont USA, 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.

K102456INTRAORAL BELSENSOR GOLDK072273BELMONT QUOLIS 5000 SERIES DENTAL UNITK062529BELMAX CM MODEL X168K041834ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CMK040748ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM

Related Devices (Code: EHD)

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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