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FDA 510(k)

AC ADAPTER:MODELS 9525,9526,9527

K-Number: K781535 · 1978-09-15

ApplicantEdwards Laboratories
Decision Date1978-09-15
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AC ADAPTER:MODELS 9525,9526,9527 is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Laboratories. It received FDA 510(k) clearance on 1978-09-15 under 510(k) number K781535. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AC ADAPTER:MODELS 9525,9526,9527?

AC ADAPTER:MODELS 9525,9526,9527 is a medical device that received FDA 510(k) clearance on 1978-09-15. The listed applicant is Edwards Laboratories. The 510(k) number is K781535.

When did AC ADAPTER:MODELS 9525,9526,9527 receive FDA 510(k) clearance?

AC ADAPTER:MODELS 9525,9526,9527 received FDA 510(k) clearance on 1978-09-15, under 510(k) number K781535.

Who is the listed applicant for AC ADAPTER:MODELS 9525,9526,9527?

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

What is the FDA product code for AC ADAPTER:MODELS 9525,9526,9527?

The FDA product code for AC ADAPTER:MODELS 9525,9526,9527 is DXG.

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Other records listing Edwards 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.

K801552MOD. 9542 FLOW-THRU INJECT. TEMP. SENSORK800655MODEL 100 SPECTRAVIEWK792441CARPENTIER-EDWARDS FLEX. ANNULOPLASTYK792034INTEGRAL DISPOSABLE HOLDER CARPENTIERK790047CARDIAC OUTPUT COMPUTER, MDEL 9520AK790022DISPOSABLE HOLDER FOR BIOPROSTHESIS

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Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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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