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FDA 510(k)

THERAPAX HT 150T

K-Number: K861431 · 1986-05-21

ApplicantOld Delft Corp. of America
Decision Date1986-05-21
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERAPAX HT 150T 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 1986-05-21 under 510(k) number K861431. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAPAX HT 150T?

THERAPAX HT 150T is a medical device that received FDA 510(k) clearance on 1986-05-21. The listed applicant is Old Delft Corp. of America. The 510(k) number is K861431.

When did THERAPAX HT 150T receive FDA 510(k) clearance?

THERAPAX HT 150T received FDA 510(k) clearance on 1986-05-21, under 510(k) number K861431.

Who is the listed applicant for THERAPAX HT 150T?

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 THERAPAX HT 150T?

The FDA product code for THERAPAX HT 150T is JAD.

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.

K862616AMBER-CHESTK854410VERIFLEX

Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, Inc.

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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