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FDA 510(k)

ALPHA-I

K-Number: K832642 · 1983-11-21

ApplicantJohnson Flexgroup
Decision Date1983-11-21
Product CodeLHC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ALPHA-I is the device name listed in this FDA 510(k) record. The listed applicant is Johnson Flexgroup. It received FDA 510(k) clearance on 1983-11-21 under 510(k) number K832642. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA-I?

ALPHA-I is a medical device that received FDA 510(k) clearance on 1983-11-21. The listed applicant is Johnson Flexgroup. The 510(k) number is K832642.

When did ALPHA-I receive FDA 510(k) clearance?

ALPHA-I received FDA 510(k) clearance on 1983-11-21, under 510(k) number K832642.

Who is the listed applicant for ALPHA-I?

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

What is the FDA product code for ALPHA-I?

The FDA product code for ALPHA-I is LHC.

Related Clinical Trials

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Related Devices (Code: LHC)

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.

K153713Getinge Series Warming CabinetGetinge Sourcing, LLCK152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc.K083417INTRATEMP SOLUTION WARMERC Change Surgical, LLCK080609SWC/DWC WARMING CABINETSMac MedicalK051819C CHANGE SOLUTION WARMERC Change Surgical, LLCK023282ORS-3000LDO.R. Solutions, 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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