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FDA 510(k)

ARCHIMED 4210 AND 4220

K-Number: K973922 · 1998-05-12

ApplicantBiosound Esaote, Inc.
Decision Date1998-05-12
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

ARCHIMED 4210 AND 4220 is the device name listed in this FDA 510(k) record. The listed applicant is Biosound Esaote, Inc.. It received FDA 510(k) clearance on 1998-05-12 under 510(k) number K973922. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHIMED 4210 AND 4220?

ARCHIMED 4210 AND 4220 is a medical device that received FDA 510(k) clearance on 1998-05-12. The listed applicant is Biosound Esaote, Inc.. The 510(k) number is K973922.

When did ARCHIMED 4210 AND 4220 receive FDA 510(k) clearance?

ARCHIMED 4210 AND 4220 received FDA 510(k) clearance on 1998-05-12, under 510(k) number K973922.

Who is the listed applicant for ARCHIMED 4210 AND 4220?

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

What is the FDA product code for ARCHIMED 4210 AND 4220?

The FDA product code for ARCHIMED 4210 AND 4220 is LOS.

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Other records listing Biosound Esaote, Inc. as applicant

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Related Devices (Code: LOS)

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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