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FDA 510(k)

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A

K-Number: K033770 · 2004-04-08

ApplicantIsoaid, LLC
Decision Date2004-04-08
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A is the device name listed in this FDA 510(k) record. The listed applicant is Isoaid, LLC. It received FDA 510(k) clearance on 2004-04-08 under 510(k) number K033770. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOAID ADVANTAGE PD-103, MODEL IAPD-103A?

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A is a medical device that received FDA 510(k) clearance on 2004-04-08. The listed applicant is Isoaid, LLC. The 510(k) number is K033770.

When did ISOAID ADVANTAGE PD-103, MODEL IAPD-103A receive FDA 510(k) clearance?

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A received FDA 510(k) clearance on 2004-04-08, under 510(k) number K033770.

Who is the listed applicant for ISOAID ADVANTAGE PD-103, MODEL IAPD-103A?

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

What is the FDA product code for ISOAID ADVANTAGE PD-103, MODEL IAPD-103A?

The FDA product code for ISOAID ADVANTAGE PD-103, MODEL IAPD-103A is KXK.

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Other records listing Isoaid, LLC 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.

K242818IsoSphereK113210ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KITK091117ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA

Related Devices (Code: KXK)

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

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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