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FDA 510(k)

PATIENT DOSE MONITOR

K-Number: K912249 · 1991-08-30

ApplicantTheta Systems, Inc.
Decision Date1991-08-30
Product CodeKPZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PATIENT DOSE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Theta Systems, Inc.. It received FDA 510(k) clearance on 1991-08-30 under 510(k) number K912249. The device is classified under product code KPZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT DOSE MONITOR?

PATIENT DOSE MONITOR is a medical device that received FDA 510(k) clearance on 1991-08-30. The listed applicant is Theta Systems, Inc.. The 510(k) number is K912249.

When did PATIENT DOSE MONITOR receive FDA 510(k) clearance?

PATIENT DOSE MONITOR received FDA 510(k) clearance on 1991-08-30, under 510(k) number K912249.

Who is the listed applicant for PATIENT DOSE MONITOR?

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

What is the FDA product code for PATIENT DOSE MONITOR?

The FDA product code for PATIENT DOSE MONITOR is KPZ.

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 Theta Systems, 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.

K912250ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES

Related Devices (Code: KPZ)

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.

K86046937-701-1 PATIENT DOASE MONITOR WITH DETECTORSVictoreen, Inc.K854410VERIFLEXOld Delft Corp. of America

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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