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FDA 510(k)

TEMPERATURE CONTROLLER MODEL 17000

K-Number: K781530 · 1978-11-14

Decision Date1978-11-14
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TEMPERATURE CONTROLLER MODEL 17000 is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1978-11-14 under 510(k) number K781530. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPERATURE CONTROLLER MODEL 17000?

TEMPERATURE CONTROLLER MODEL 17000 is a medical device that received FDA 510(k) clearance on 1978-11-14. The listed applicant is Healthdyne, Inc.. The 510(k) number is K781530.

When did TEMPERATURE CONTROLLER MODEL 17000 receive FDA 510(k) clearance?

TEMPERATURE CONTROLLER MODEL 17000 received FDA 510(k) clearance on 1978-11-14, under 510(k) number K781530.

Who is the listed applicant for TEMPERATURE CONTROLLER MODEL 17000?

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

What is the FDA product code for TEMPERATURE CONTROLLER MODEL 17000?

The FDA product code for TEMPERATURE CONTROLLER MODEL 17000 is BZE.

Related Clinical Trials

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.

Other records listing Healthdyne, 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.

View all 35 devices →

Related Devices (Code: BZE)

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.

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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