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FDA 510(k)

AUDIOMETER CALIBRATOR MODEL RA 310

K-Number: K780474 · 1978-03-30

ApplicantTracor Instruments, Inc.
Decision Date1978-03-30
Product CodeEWA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOMETER CALIBRATOR MODEL RA 310 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 1978-03-30 under 510(k) number K780474. The device is classified under product code EWA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDIOMETER CALIBRATOR MODEL RA 310?

AUDIOMETER CALIBRATOR MODEL RA 310 is a medical device that received FDA 510(k) clearance on 1978-03-30. The listed applicant is Tracor Instruments, Inc.. The 510(k) number is K780474.

When did AUDIOMETER CALIBRATOR MODEL RA 310 receive FDA 510(k) clearance?

AUDIOMETER CALIBRATOR MODEL RA 310 received FDA 510(k) clearance on 1978-03-30, under 510(k) number K780474.

Who is the listed applicant for AUDIOMETER CALIBRATOR MODEL RA 310?

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 AUDIOMETER CALIBRATOR MODEL RA 310?

The FDA product code for AUDIOMETER CALIBRATOR MODEL RA 310 is EWA.

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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 SOMATOSENSORYK781743RESPONSE SYSTEM, TN-3000

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Related Devices (Code: EWA)

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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