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FDA 510(k)

WITT BIOMEDICAL VX-80

K-Number: K880258 · 1988-06-16

ApplicantWitt Biomedical Corporation
Decision Date1988-06-16
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WITT BIOMEDICAL VX-80 is the device name listed in this FDA 510(k) record. The listed applicant is Witt Biomedical Corporation. It received FDA 510(k) clearance on 1988-06-16 under 510(k) number K880258. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WITT BIOMEDICAL VX-80?

WITT BIOMEDICAL VX-80 is a medical device that received FDA 510(k) clearance on 1988-06-16. The listed applicant is Witt Biomedical Corporation. The 510(k) number is K880258.

When did WITT BIOMEDICAL VX-80 receive FDA 510(k) clearance?

WITT BIOMEDICAL VX-80 received FDA 510(k) clearance on 1988-06-16, under 510(k) number K880258.

Who is the listed applicant for WITT BIOMEDICAL VX-80?

The FDA 510(k) record lists Witt Biomedical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WITT BIOMEDICAL VX-80?

The FDA product code for WITT BIOMEDICAL VX-80 is DXG.

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Other records listing Witt Biomedical Corporation 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.

K010058IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORKK973474WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITSK950436WITT BIOMEDICAL SERIES IVK945582WITT BIOMEDICAL IMAGE IIIK923054WITT BIOMEDICAL SERIES II-EP

Related Devices (Code: DXG)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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