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FDA 510(k)

DIGITRACE HOME VIDEO SYSTEM

K-Number: K955787 · 1996-02-09

ApplicantNew England Medical Instruments, Inc.
Decision Date1996-02-09
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DIGITRACE HOME VIDEO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is New England Medical Instruments, Inc.. It received FDA 510(k) clearance on 1996-02-09 under 510(k) number K955787. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITRACE HOME VIDEO SYSTEM?

DIGITRACE HOME VIDEO SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is New England Medical Instruments, Inc.. The 510(k) number is K955787.

When did DIGITRACE HOME VIDEO SYSTEM receive FDA 510(k) clearance?

DIGITRACE HOME VIDEO SYSTEM received FDA 510(k) clearance on 1996-02-09, under 510(k) number K955787.

Who is the listed applicant for DIGITRACE HOME VIDEO SYSTEM?

The FDA 510(k) record lists New England Medical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITRACE HOME VIDEO SYSTEM?

The FDA product code for DIGITRACE HOME VIDEO SYSTEM is OMB.

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Other records listing New England Medical 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.

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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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