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FDA 510(k)

BETA-CAP II ADAPTER

K-Number: K801680 · 1980-08-04

ApplicantQuinton, Inc.
Decision Date1980-08-04
Product CodeGCE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BETA-CAP II ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K801680. The device is classified under product code GCE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETA-CAP II ADAPTER?

BETA-CAP II ADAPTER is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Quinton, Inc.. The 510(k) number is K801680.

When did BETA-CAP II ADAPTER receive FDA 510(k) clearance?

BETA-CAP II ADAPTER received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801680.

Who is the listed applicant for BETA-CAP II ADAPTER?

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

What is the FDA product code for BETA-CAP II ADAPTER?

The FDA product code for BETA-CAP II ADAPTER is GCE.

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Other records listing Quinton, Inc. as applicant

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Related Devices (Code: GCE)

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.

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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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