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FDA 510(k)

FLAATZ 500

K-Number: K091747 · 2009-07-01

ApplicantDrtech Corp.
Decision Date2009-07-01
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLAATZ 500 is the device name listed in this FDA 510(k) record. The listed applicant is Drtech Corp.. It received FDA 510(k) clearance on 2009-07-01 under 510(k) number K091747. 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 FLAATZ 500?

FLAATZ 500 is a medical device that received FDA 510(k) clearance on 2009-07-01. The listed applicant is Drtech Corp.. The 510(k) number is K091747.

When did FLAATZ 500 receive FDA 510(k) clearance?

FLAATZ 500 received FDA 510(k) clearance on 2009-07-01, under 510(k) number K091747.

Who is the listed applicant for FLAATZ 500?

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

What is the FDA product code for FLAATZ 500?

The FDA product code for FLAATZ 500 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 Drtech Corp. 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.

K111655FLAATZ 760K111583FLAATZ 560K102474FLAATZ 750EK080064FLAATZ 750

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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