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FDA 510(k)

INTRA VAGINAL TRANSDUCER

K-Number: K853407 · 1985-09-27

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1985-09-27
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTRA VAGINAL TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1985-09-27 under 510(k) number K853407. The device is classified under product code HEM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA VAGINAL TRANSDUCER?

INTRA VAGINAL TRANSDUCER is a medical device that received FDA 510(k) clearance on 1985-09-27. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K853407.

When did INTRA VAGINAL TRANSDUCER receive FDA 510(k) clearance?

INTRA VAGINAL TRANSDUCER received FDA 510(k) clearance on 1985-09-27, under 510(k) number K853407.

Who is the listed applicant for INTRA VAGINAL TRANSDUCER?

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

What is the FDA product code for INTRA VAGINAL TRANSDUCER?

The FDA product code for INTRA VAGINAL TRANSDUCER is HEM.

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Related Devices (Code: HEM)

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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