Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PHYNE-VU

K-Number: K885096 · 1989-07-25

ApplicantMedical Resources, Ltd.
Decision Date1989-07-25
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PHYNE-VU is the device name listed in this FDA 510(k) record. The listed applicant is Medical Resources, Ltd.. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K885096. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYNE-VU?

PHYNE-VU is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Medical Resources, Ltd.. The 510(k) number is K885096.

When did PHYNE-VU receive FDA 510(k) clearance?

PHYNE-VU received FDA 510(k) clearance on 1989-07-25, under 510(k) number K885096.

Who is the listed applicant for PHYNE-VU?

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

What is the FDA product code for PHYNE-VU?

The FDA product code for PHYNE-VU is FRO. This falls under the Anesthesiology category.

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 Resources, Ltd. 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.

K931250PHYNE-TOUCH PFK914628PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIFK903559HIGH RISKK895195CHEMO-TOUCHK894212PHYNE-TOUCH-STERILEK890983PHYNE-TOUCH (PATIENT EXAMINATION GLOVES)

View all 7 devices →

Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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.

↑