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FDA 510(k)

BRAIN HEART INFUSION W/O DEXTROSE

K-Number: K811353 · 1981-05-29

ApplicantAcumedia Manufacturers, Inc.
Decision Date1981-05-29
Product CodeJSG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BRAIN HEART INFUSION W/O DEXTROSE is the device name listed in this FDA 510(k) record. The listed applicant is Acumedia Manufacturers, Inc.. It received FDA 510(k) clearance on 1981-05-29 under 510(k) number K811353. The device is classified under product code JSG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAIN HEART INFUSION W/O DEXTROSE?

BRAIN HEART INFUSION W/O DEXTROSE is a medical device that received FDA 510(k) clearance on 1981-05-29. The listed applicant is Acumedia Manufacturers, Inc.. The 510(k) number is K811353.

When did BRAIN HEART INFUSION W/O DEXTROSE receive FDA 510(k) clearance?

BRAIN HEART INFUSION W/O DEXTROSE received FDA 510(k) clearance on 1981-05-29, under 510(k) number K811353.

Who is the listed applicant for BRAIN HEART INFUSION W/O DEXTROSE?

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

What is the FDA product code for BRAIN HEART INFUSION W/O DEXTROSE?

The FDA product code for BRAIN HEART INFUSION W/O DEXTROSE is JSG.

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Other records listing Acumedia Manufacturers, Inc. 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.

K881534ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGARK881540FLO AGARK881544LITTMAN AGARK881561TERGITOL 7 BROTHK881575SELECTIVE STREPTOCOCCUS AGARK881569STUARTS TRANSPORT MEDIUM

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Related Devices (Code: JSG)

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.

K882495THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007Lakewood Biochemical Co., Inc.K881558TRYPTOSE AGARAcumedia Manufacturers, Inc.K881550OF BASAL MEDIUMAcumedia Manufacturers, Inc.K881557TRYPTONEAcumedia Manufacturers, Inc.K881564TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACTAcumedia Manufacturers, Inc.K881533BLOOD AGAR BASE NO. 2Acumedia 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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