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FDA 510(k)

PRISTINE

K-Number: K844236 · 1984-11-21

ApplicantMedical Dimensions
Decision Date1984-11-21
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRISTINE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Dimensions. It received FDA 510(k) clearance on 1984-11-21 under 510(k) number K844236. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISTINE?

PRISTINE is a medical device that received FDA 510(k) clearance on 1984-11-21. The listed applicant is Medical Dimensions. The 510(k) number is K844236.

When did PRISTINE receive FDA 510(k) clearance?

PRISTINE received FDA 510(k) clearance on 1984-11-21, under 510(k) number K844236.

Who is the listed applicant for PRISTINE?

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

What is the FDA product code for PRISTINE?

The FDA product code for PRISTINE is KGO.

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 Medical Dimensions 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.

K853103MCKNIFE

Related Devices (Code: KGO)

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.

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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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