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FDA 510(k)

MODEL 78353B

K-Number: K842817 · 1985-06-06

ApplicantHewlett-Packard Co.
Decision Date1985-06-06
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 78353B 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 1985-06-06 under 510(k) number K842817. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 78353B?

MODEL 78353B is a medical device that received FDA 510(k) clearance on 1985-06-06. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K842817.

When did MODEL 78353B receive FDA 510(k) clearance?

MODEL 78353B received FDA 510(k) clearance on 1985-06-06, under 510(k) number K842817.

Who is the listed applicant for MODEL 78353B?

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 78353B?

The FDA product code for MODEL 78353B is DRT.

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Other records listing Hewlett-Packard Co. as applicant

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Related Devices (Code: DRT)

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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