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FDA 510(k)

MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION

K-Number: K910291 · 1991-04-22

ApplicantHewlett-Packard Co.
Decision Date1991-04-22
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1991-04-22 under 510(k) number K910291. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION?

MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-04-22. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K910291.

When did MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION receive FDA 510(k) clearance?

MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION received FDA 510(k) clearance on 1991-04-22, under 510(k) number K910291.

Who is the listed applicant for MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION?

The FDA product code for MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION is DSI.

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Other records listing Hewlett-Packard Co. as applicant

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Related Devices (Code: DSI)

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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