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FDA 510(k)

MODEL 405

K-Number: K904606 · 1991-03-01

ApplicantIvy Biomedical Systems, Inc.
Decision Date1991-03-01
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 405 is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 1991-03-01 under 510(k) number K904606. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 405?

MODEL 405 is a medical device that received FDA 510(k) clearance on 1991-03-01. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K904606.

When did MODEL 405 receive FDA 510(k) clearance?

MODEL 405 received FDA 510(k) clearance on 1991-03-01, under 510(k) number K904606.

Who is the listed applicant for MODEL 405?

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

What is the FDA product code for MODEL 405?

The FDA product code for MODEL 405 is DPS.

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Related Devices (Code: DPS)

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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