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FDA 510(k)

TRANSPAC(R) II, DISPOSABLE TRANSDUCER

K-Number: K884823 · 1990-07-03

Decision Date1990-07-03
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRANSPAC(R) II, DISPOSABLE TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1990-07-03 under 510(k) number K884823. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSPAC(R) II, DISPOSABLE TRANSDUCER?

TRANSPAC(R) II, DISPOSABLE TRANSDUCER is a medical device that received FDA 510(k) clearance on 1990-07-03. The listed applicant is Abbott Laboratories. The 510(k) number is K884823.

When did TRANSPAC(R) II, DISPOSABLE TRANSDUCER receive FDA 510(k) clearance?

TRANSPAC(R) II, DISPOSABLE TRANSDUCER received FDA 510(k) clearance on 1990-07-03, under 510(k) number K884823.

Who is the listed applicant for TRANSPAC(R) II, DISPOSABLE TRANSDUCER?

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

What is the FDA product code for TRANSPAC(R) II, DISPOSABLE TRANSDUCER?

The FDA product code for TRANSPAC(R) II, DISPOSABLE TRANSDUCER is GWM.

Related Clinical Trials

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.

Other records listing Abbott Laboratories 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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Related Devices (Code: GWM)

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.

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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