FDA 510(k)

7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)

K-Number: K911044 · 1991-10-07

Decision Date1991-10-07

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Equipment B.V.. It received FDA 510(k) clearance on 1991-10-07 under 510(k) number K911044. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)?

7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) is a medical device that received FDA 510(k) clearance on 1991-10-07. The listed applicant is Pie Medical Equipment B.V.. The 510(k) number is K911044.

When did 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) receive FDA 510(k) clearance?

7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) received FDA 510(k) clearance on 1991-10-07, under 510(k) number K911044.

Who is the listed applicant for 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)?

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

What is the FDA product code for 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)?

The FDA product code for 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) is ITX.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pie Medical Equipment B.V. as applicant

K982203CAAS II LVA BIPLANE OPTION K945540CAAS II K915647DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250 K912819SC1150 CW/PD K911584DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 K911043HEMISPHERE MULTIPLANE ENDORECTAL PROBE

View all 8 devices →

Related Devices (Code: ITX)

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm Corporation K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLC K261014Accuro® 3S Needle Guide KitRivanna Medical, 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.