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FDA 510(k)

PEM-C

K-Number: K830397 · 1983-04-12

ApplicantHealth Development Corp.
Decision Date1983-04-12
Product CodeJSF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PEM-C is the device name listed in this FDA 510(k) record. The listed applicant is Health Development Corp.. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830397. The device is classified under product code JSF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEM-C?

PEM-C is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Health Development Corp.. The 510(k) number is K830397.

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

PEM-C received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830397.

Who is the listed applicant for PEM-C?

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

What is the FDA product code for PEM-C?

The FDA product code for PEM-C is JSF.

Other records listing Health Development Corp. 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.

K823937SEMINAL COLLECTION DEVICEK810499PERCUTANEOUS GASTROINTESTINAL TUBEK802482KEOFEED (R) EASY-FILL ENTERIC FEED BAGK791714SURGIFEED

Related Devices (Code: JSF)

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.

K880946NUTRIENT GELATIN - PRODUCT NUMBER T2860Lakewood Biochemical Co., Inc.K880126LAURYL TRYPTOSE BROTHHardy MediaK880119MOELLERS DECARBOXYLASE, ONITHINEHardy MediaK880120MOELLERS DECARBOXYLASE, LYSINEHardy MediaK880139ONPG TEST REAGENTHardy MediaK880113CYSTINE TRYPTIC MEDIUM W/LACTOSEHardy Media

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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