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FDA 510(k)

BREATHING ZONE

K-Number: K831067 · 1983-06-16

ApplicantUpper Four, Inc.
Decision Date1983-06-16
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BREATHING ZONE is the device name listed in this FDA 510(k) record. The listed applicant is Upper Four, Inc.. It received FDA 510(k) clearance on 1983-06-16 under 510(k) number K831067. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHING ZONE?

BREATHING ZONE is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Upper Four, Inc.. The 510(k) number is K831067.

When did BREATHING ZONE receive FDA 510(k) clearance?

BREATHING ZONE received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831067.

Who is the listed applicant for BREATHING ZONE?

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

What is the FDA product code for BREATHING ZONE?

The FDA product code for BREATHING ZONE is FRF.

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Related Devices (Code: FRF)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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