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FDA 510(k)

POLYGRAM NET BIOFEEDBACK APPLICATION

K-Number: K041244 · 2004-08-12

ApplicantMedtronic Vascular
Decision Date2004-08-12
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

POLYGRAM NET BIOFEEDBACK APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2004-08-12 under 510(k) number K041244. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYGRAM NET BIOFEEDBACK APPLICATION?

POLYGRAM NET BIOFEEDBACK APPLICATION is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Medtronic Vascular. The 510(k) number is K041244.

When did POLYGRAM NET BIOFEEDBACK APPLICATION receive FDA 510(k) clearance?

POLYGRAM NET BIOFEEDBACK APPLICATION received FDA 510(k) clearance on 2004-08-12, under 510(k) number K041244.

Who is the listed applicant for POLYGRAM NET BIOFEEDBACK APPLICATION?

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

What is the FDA product code for POLYGRAM NET BIOFEEDBACK APPLICATION?

The FDA product code for POLYGRAM NET BIOFEEDBACK APPLICATION is HCC.

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Related Devices (Code: HCC)

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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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