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FDA 510(k)

NEONATAL SCREENING AUDIOMETER

K-Number: K780150 · 1978-02-13

ApplicantTelediagnostic Systems, Inc.
Decision Date1978-02-13
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NEONATAL SCREENING AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Telediagnostic Systems, Inc.. It received FDA 510(k) clearance on 1978-02-13 under 510(k) number K780150. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL SCREENING AUDIOMETER?

NEONATAL SCREENING AUDIOMETER is a medical device that received FDA 510(k) clearance on 1978-02-13. The listed applicant is Telediagnostic Systems, Inc.. The 510(k) number is K780150.

When did NEONATAL SCREENING AUDIOMETER receive FDA 510(k) clearance?

NEONATAL SCREENING AUDIOMETER received FDA 510(k) clearance on 1978-02-13, under 510(k) number K780150.

Who is the listed applicant for NEONATAL SCREENING AUDIOMETER?

The FDA 510(k) record lists Telediagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEONATAL SCREENING AUDIOMETER?

The FDA product code for NEONATAL SCREENING AUDIOMETER is EWO.

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Related Devices (Code: EWO)

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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