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FDA 510(k)

ENGSTROM METABOLIC COMPUTER

K-Number: K821344 · 1982-05-28

ApplicantLkb Instruments, Inc.
Decision Date1982-05-28
Product CodeBZL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENGSTROM METABOLIC COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821344. The device is classified under product code BZL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGSTROM METABOLIC COMPUTER?

ENGSTROM METABOLIC COMPUTER is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K821344.

When did ENGSTROM METABOLIC COMPUTER receive FDA 510(k) clearance?

ENGSTROM METABOLIC COMPUTER received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821344.

Who is the listed applicant for ENGSTROM METABOLIC COMPUTER?

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

What is the FDA product code for ENGSTROM METABOLIC COMPUTER?

The FDA product code for ENGSTROM METABOLIC COMPUTER is BZL.

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Other records listing Lkb Instruments, Inc. as applicant

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K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTERK872955DELFIA(TM) FERRITIN KITK871303DELFIA(TM) THYROXINE (T4) KITK871599DELFIA(TM) HIGE KITK871644DELFIA (TM) HTSH KITK864452DELFIA(TM) TRIIODOTHYRONINE (T3) KIT

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Related Devices (Code: BZL)

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.

K200076Breezing MedTf Health Co.K190561NICU V'02Cosmed Nordic ApsK110810ANASCIENT BREATH MONITORInvoy Technologies, LLCK093080METAPHOR METABOLIC MONITORTreymed, Inc.K071533FITMATE SERIESCosmed SrlK070858EXPRESS SERIESMedical Graphics Corp.

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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