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FDA 510(k)

AMBER DU

K-Number: K973219 · 1997-10-08

ApplicantOldelft Corp. of America
Decision Date1997-10-08
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMBER DU is the device name listed in this FDA 510(k) record. The listed applicant is Oldelft Corp. of America. It received FDA 510(k) clearance on 1997-10-08 under 510(k) number K973219. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBER DU?

AMBER DU is a medical device that received FDA 510(k) clearance on 1997-10-08. The listed applicant is Oldelft Corp. of America. The 510(k) number is K973219.

When did AMBER DU receive FDA 510(k) clearance?

AMBER DU received FDA 510(k) clearance on 1997-10-08, under 510(k) number K973219.

Who is the listed applicant for AMBER DU?

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

What is the FDA product code for AMBER DU?

The FDA product code for AMBER DU is KPR.

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Other records listing Oldelft Corp. of America 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.

K980296OLDELFT DIGIDELCAK946128SIMULIX-HPK950037N 800 HFK932848SIMULIX-MC CT EXTENSIONK923584THERAPAX DXT 300 SERIES 3K914784PAPILLION PROCTOSCOPE

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Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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