FDA 510(k)

PEM-T

K-Number: K830497 · 1983-04-05

ApplicantHedeco

Decision Date1983-04-05

Product CodeJWZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

PEM-T is the device name listed in this FDA 510(k) record. The listed applicant is Hedeco. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830497. The device is classified under product code JWZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEM-T?

PEM-T is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Hedeco. The 510(k) number is K830497.

When did PEM-T receive FDA 510(k) clearance?

PEM-T received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830497.

Who is the listed applicant for PEM-T?

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

What is the FDA product code for PEM-T?

The FDA product code for PEM-T is JWZ.

Other records listing Hedeco 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.

K822380ROMBEAU GASTROSTOMY-JEJUNAL TUBE K820063KEOFEED 500 ENTERIC FEEDING PUMP K812507THE KEOFEED STOMACH TUBE

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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.