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FDA 510(k)

MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER

K-Number: K844916 · 1985-04-22

ApplicantHoffrel Instruments, Inc.
Decision Date1985-04-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER 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 1985-04-22 under 510(k) number K844916. 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 MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER?

MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER is a medical device that received FDA 510(k) clearance on 1985-04-22. The listed applicant is Hoffrel Instruments, Inc.. The 510(k) number is K844916.

When did MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER receive FDA 510(k) clearance?

MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER received FDA 510(k) clearance on 1985-04-22, under 510(k) number K844916.

Who is the listed applicant for MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER?

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 MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER?

The FDA product code for MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER 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-MOD417K834277MOD 427K834276MOD 456K837282MODEL VPS VASCULAR PROFILE SYSTEM

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Related Devices (Code: IYO)

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.

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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