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FDA 510(k)

WITT BIOMEDICAL SERIES IV

K-Number: K950436 · 1995-11-02

ApplicantWitt Biomedical Corporation
Decision Date1995-11-02
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WITT BIOMEDICAL SERIES IV 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 1995-11-02 under 510(k) number K950436. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WITT BIOMEDICAL SERIES IV?

WITT BIOMEDICAL SERIES IV is a medical device that received FDA 510(k) clearance on 1995-11-02. The listed applicant is Witt Biomedical Corporation. The 510(k) number is K950436.

When did WITT BIOMEDICAL SERIES IV receive FDA 510(k) clearance?

WITT BIOMEDICAL SERIES IV received FDA 510(k) clearance on 1995-11-02, under 510(k) number K950436.

Who is the listed applicant for WITT BIOMEDICAL SERIES IV?

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 SERIES IV?

The FDA product code for WITT BIOMEDICAL SERIES IV is MHX.

Related Clinical Trials

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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 UNITSK945582WITT BIOMEDICAL IMAGE IIIK923054WITT BIOMEDICAL SERIES II-EPK880258WITT BIOMEDICAL VX-80

Related Devices (Code: MHX)

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

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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