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FDA 510(k)

RESPONSE SYSTEM, TN-3000

K-Number: K781743 · 1978-12-01

ApplicantTracor Instruments, Inc.
Decision Date1978-12-01
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RESPONSE SYSTEM, TN-3000 is the device name listed in this FDA 510(k) record. The listed applicant is Tracor Instruments, Inc.. It received FDA 510(k) clearance on 1978-12-01 under 510(k) number K781743. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPONSE SYSTEM, TN-3000?

RESPONSE SYSTEM, TN-3000 is a medical device that received FDA 510(k) clearance on 1978-12-01. The listed applicant is Tracor Instruments, Inc.. The 510(k) number is K781743.

When did RESPONSE SYSTEM, TN-3000 receive FDA 510(k) clearance?

RESPONSE SYSTEM, TN-3000 received FDA 510(k) clearance on 1978-12-01, under 510(k) number K781743.

Who is the listed applicant for RESPONSE SYSTEM, TN-3000?

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

What is the FDA product code for RESPONSE SYSTEM, TN-3000?

The FDA product code for RESPONSE SYSTEM, TN-3000 is GWL.

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Other records listing Tracor 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.

K853245TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETERK851392TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200K822414TRACOR RA400 AUDIOMETERK790903TRACOR MODEL RA-411 MICROPROCESSORK781704STIMULATOR, TN-3001 SOMATOSENSORYK780749SPEECH AUDIOMETER RA 226

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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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