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FDA 510(k)

MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER

K-Number: K860235 · 1986-05-15

ApplicantHoffrel Instruments, Inc.
Decision Date1986-05-15
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Hoffrel Instruments, Inc.. It received FDA 510(k) clearance on 1986-05-15 under 510(k) number K860235. 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 MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER?

MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER is a medical device that received FDA 510(k) clearance on 1986-05-15. The listed applicant is Hoffrel Instruments, Inc.. The 510(k) number is K860235.

When did MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER receive FDA 510(k) clearance?

MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER received FDA 510(k) clearance on 1986-05-15, under 510(k) number K860235.

Who is the listed applicant for MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER?

The FDA 510(k) record lists Hoffrel Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER?

The FDA product code for MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER is ITX.

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Other records listing Hoffrel Instruments, Inc. 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.

K870850MOD 482K850165MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417K844916MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLERK834277MOD 427K834276MOD 456K837282MODEL VPS VASCULAR PROFILE SYSTEM

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 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.

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