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FDA 510(k)

ALPHAMEDIX I/A HAND-PIECE, 500-001

K-Number: K830812 · 1983-06-08

ApplicantAlphamedix, Inc.
Decision Date1983-06-08
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ALPHAMEDIX I/A HAND-PIECE, 500-001 is the device name listed in this FDA 510(k) record. The listed applicant is Alphamedix, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K830812. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHAMEDIX I/A HAND-PIECE, 500-001?

ALPHAMEDIX I/A HAND-PIECE, 500-001 is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Alphamedix, Inc.. The 510(k) number is K830812.

When did ALPHAMEDIX I/A HAND-PIECE, 500-001 receive FDA 510(k) clearance?

ALPHAMEDIX I/A HAND-PIECE, 500-001 received FDA 510(k) clearance on 1983-06-08, under 510(k) number K830812.

Who is the listed applicant for ALPHAMEDIX I/A HAND-PIECE, 500-001?

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

What is the FDA product code for ALPHAMEDIX I/A HAND-PIECE, 500-001?

The FDA product code for ALPHAMEDIX I/A HAND-PIECE, 500-001 is HQC.

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Other records listing Alphamedix, Inc. as applicant

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K852706VERSABLADEK852633VERSABLADEK851272VERSAPHAGEK830703GLOMARKK820363DISPOSABLE SURGICAL GARMENTSK820008VERSATOME I

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Related Devices (Code: HQC)

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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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