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FDA 510(k)

AMBER-CHEST

K-Number: K862616 · 1986-09-02

ApplicantOld Delft Corp. of America
Decision Date1986-09-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMBER-CHEST is the device name listed in this FDA 510(k) record. The listed applicant is Old Delft Corp. of America. It received FDA 510(k) clearance on 1986-09-02 under 510(k) number K862616. 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-CHEST?

AMBER-CHEST is a medical device that received FDA 510(k) clearance on 1986-09-02. The listed applicant is Old Delft Corp. of America. The 510(k) number is K862616.

When did AMBER-CHEST receive FDA 510(k) clearance?

AMBER-CHEST received FDA 510(k) clearance on 1986-09-02, under 510(k) number K862616.

Who is the listed applicant for AMBER-CHEST?

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

What is the FDA product code for AMBER-CHEST?

The FDA product code for AMBER-CHEST is KPR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Old Delft 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.

K861431THERAPAX HT 150TK854410VERIFLEX

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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