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FDA 510(k)

ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202

K-Number: K800364 · 1980-03-12

ApplicantHoffrel Instruments, Inc.
Decision Date1980-03-12
Product CodeDKX
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 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 1980-03-12 under 510(k) number K800364. The device is classified under product code DKX. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202?

ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Hoffrel Instruments, Inc.. The 510(k) number is K800364.

When did ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 receive FDA 510(k) clearance?

ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800364.

Who is the listed applicant for ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202?

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, MOD. 202?

The FDA product code for ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 is DKX.

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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

View all 12 devices →

Related Devices (Code: DKX)

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.

K030211RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016Icn Biomedicals, 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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