FDA 510(k)

HR UNIT

K-Number: K782148 · 1979-01-08

Decision Date1979-01-08

Product CodeIQP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

HR UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Parke-Davis Co.. It received FDA 510(k) clearance on 1979-01-08 under 510(k) number K782148. The device is classified under product code IQP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HR UNIT?

HR UNIT is a medical device that received FDA 510(k) clearance on 1979-01-08. The listed applicant is Parke-Davis Co.. The 510(k) number is K782148.

When did HR UNIT receive FDA 510(k) clearance?

HR UNIT received FDA 510(k) clearance on 1979-01-08, under 510(k) number K782148.

Who is the listed applicant for HR UNIT?

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

What is the FDA product code for HR UNIT?

The FDA product code for HR UNIT is IQP.

Other records listing Parke-Davis Co. 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.

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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.