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FDA 510(k)

MECHANICAL OXYGEN REGULATOR

K-Number: K864127 · 1986-11-13

ApplicantTravomed, Inc.
Decision Date1986-11-13
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MECHANICAL OXYGEN REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Travomed, Inc.. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K864127. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECHANICAL OXYGEN REGULATOR?

MECHANICAL OXYGEN REGULATOR is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Travomed, Inc.. The 510(k) number is K864127.

When did MECHANICAL OXYGEN REGULATOR receive FDA 510(k) clearance?

MECHANICAL OXYGEN REGULATOR received FDA 510(k) clearance on 1986-11-13, under 510(k) number K864127.

Who is the listed applicant for MECHANICAL OXYGEN REGULATOR?

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

What is the FDA product code for MECHANICAL OXYGEN REGULATOR?

The FDA product code for MECHANICAL OXYGEN REGULATOR is NFB.

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.

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Other records listing Travomed, 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.

K854748TRAVELPAK MODEL DC-202K854747TRAVONEB MODEL # TONE 1K854509TRAVELPAK MODEL AC-102

Related Devices (Code: NFB)

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

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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