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FDA 510(k)

ULTRASONIC DIAGNOSTIC SYSTEM

K-Number: K790396 · 1979-03-21

ApplicantHoffrel Instruments, Inc.
Decision Date1979-03-21
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC DIAGNOSTIC SYSTEM 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 1979-03-21 under 510(k) number K790396. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC DIAGNOSTIC SYSTEM?

ULTRASONIC DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1979-03-21. The listed applicant is Hoffrel Instruments, Inc.. The 510(k) number is K790396.

When did ULTRASONIC DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

ULTRASONIC DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1979-03-21, under 510(k) number K790396.

Who is the listed applicant for ULTRASONIC DIAGNOSTIC SYSTEM?

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 ULTRASONIC DIAGNOSTIC SYSTEM?

The FDA product code for ULTRASONIC DIAGNOSTIC SYSTEM is IYO.

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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 482K860235MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCERK850165MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417K844916MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLERK834276MOD 456K834277MOD 427

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Related Devices (Code: IYO)

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K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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