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FDA 510(k)

MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR

K-Number: K864261 · 1987-03-27

ApplicantBio-Dyne, Inc.
Decision Date1987-03-27
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Dyne, Inc.. It received FDA 510(k) clearance on 1987-03-27 under 510(k) number K864261. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR?

MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 1987-03-27. The listed applicant is Bio-Dyne, Inc.. The 510(k) number is K864261.

When did MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR receive FDA 510(k) clearance?

MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR received FDA 510(k) clearance on 1987-03-27, under 510(k) number K864261.

Who is the listed applicant for MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR?

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

What is the FDA product code for MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR?

The FDA product code for MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR is BZQ.

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Other records listing Bio-Dyne, Inc. as applicant

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.

K900691BIODYNE INSTRUMENT WIPESK883984HEMORX COLD PACK

Related Devices (Code: BZQ)

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

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