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FDA 510(k)

BRAIN HEART INFUSION

K-Number: K821597 · 1982-07-08

ApplicantHardy Media
Decision Date1982-07-08
Product CodeJSC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BRAIN HEART INFUSION is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Media. It received FDA 510(k) clearance on 1982-07-08 under 510(k) number K821597. The device is classified under product code JSC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAIN HEART INFUSION?

BRAIN HEART INFUSION is a medical device that received FDA 510(k) clearance on 1982-07-08. The listed applicant is Hardy Media. The 510(k) number is K821597.

When did BRAIN HEART INFUSION receive FDA 510(k) clearance?

BRAIN HEART INFUSION received FDA 510(k) clearance on 1982-07-08, under 510(k) number K821597.

Who is the listed applicant for BRAIN HEART INFUSION?

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

What is the FDA product code for BRAIN HEART INFUSION?

The FDA product code for BRAIN HEART INFUSION is JSC.

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Other records listing Hardy Media 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.

K880134MIDDLEBROOK 7H11 AGARK880122MIDDLEBROOK 7H9 BROTHK880131LOWENSTEIN-JENSEN, GRUFTK880133MIL MEDIUMK880126LAURYL TRYPTOSE BROTHK880116MRVP BROTH

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Related Devices (Code: JSC)

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.

K850143SPORDEX CULTURE MEDIAAmerican Sterilizer Co.K842852BRAIN HEART INFUSION BROTHAnarobe SystemsK842849TRYPTICASE SOY BROTHAnarobe SystemsK841221BRAIN HEART INFUSION BROTHAnaerobe SystemsK841219SHOPPED MEAT CARBOHYDRATEAnaerobe SystemsK833300SABOURAUD BHI AGARAcumedia Manufacturers, Inc.

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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