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FDA 510(k)

PATIENT MONITOR MODEL 405P

K-Number: K955546 · 1996-08-16

ApplicantIvy Biomedical Systems, Inc.
Decision Date1996-08-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PATIENT MONITOR MODEL 405P 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 1996-08-16 under 510(k) number K955546. 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 PATIENT MONITOR MODEL 405P?

PATIENT MONITOR MODEL 405P is a medical device that received FDA 510(k) clearance on 1996-08-16. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K955546.

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

PATIENT MONITOR MODEL 405P received FDA 510(k) clearance on 1996-08-16, under 510(k) number K955546.

Who is the listed applicant for PATIENT MONITOR MODEL 405P?

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 PATIENT MONITOR MODEL 405P?

The FDA product code for PATIENT MONITOR MODEL 405P is DPS.

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Related Devices (Code: DPS)

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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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