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FDA 510(k)

MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR

K-Number: K880066 · 1988-03-22

ApplicantIvy Biomedical Systems, Inc.
Decision Date1988-03-22
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR 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 1988-03-22 under 510(k) number K880066. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR?

MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR is a medical device that received FDA 510(k) clearance on 1988-03-22. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K880066.

When did MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR receive FDA 510(k) clearance?

MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR received FDA 510(k) clearance on 1988-03-22, under 510(k) number K880066.

Who is the listed applicant for MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR?

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 303D AND 403D ADULT HEART RATE & RESPIRATOR?

The FDA product code for MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR is DRT.

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Related Devices (Code: DRT)

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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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