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FDA 510(k)

MOD 427

K-Number: K834277 · 1984-02-17

ApplicantHoffrel Instruments, Inc.
Decision Date1984-02-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOD 427 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 1984-02-17 under 510(k) number K834277. 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 MOD 427?

MOD 427 is a medical device that received FDA 510(k) clearance on 1984-02-17. The listed applicant is Hoffrel Instruments, Inc.. The 510(k) number is K834277.

When did MOD 427 receive FDA 510(k) clearance?

MOD 427 received FDA 510(k) clearance on 1984-02-17, under 510(k) number K834277.

Who is the listed applicant for MOD 427?

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 427?

The FDA product code for MOD 427 is IYO.

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 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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