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FDA 510(k)

0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER

K-Number: K961208 · 1996-06-17

ApplicantPtw-New York Corp.
Decision Date1996-06-17
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Ptw-New York Corp.. It received FDA 510(k) clearance on 1996-06-17 under 510(k) number K961208. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER?

0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER is a medical device that received FDA 510(k) clearance on 1996-06-17. The listed applicant is Ptw-New York Corp.. The 510(k) number is K961208.

When did 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER receive FDA 510(k) clearance?

0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER received FDA 510(k) clearance on 1996-06-17, under 510(k) number K961208.

Who is the listed applicant for 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER?

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

What is the FDA product code for 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER?

The FDA product code for 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER is IYE.

Related Clinical Trials

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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 Ptw-New York 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.

K062817PTW DAVID IMRT QC VERIFICATION SYSTEMK010705OPTIDOSK010916PTW DOSIMETRY DIODE, T60008K972211MULTIDOS, QC6PLUSK9722120.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBERK954165PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM

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Related Devices (Code: IYE)

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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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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