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FDA 510(k)

TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)

K-Number: K962944 · 1996-10-23

ApplicantTranstracheal Systems
Decision Date1996-10-23
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) is the device name listed in this FDA 510(k) record. The listed applicant is Transtracheal Systems. It received FDA 510(k) clearance on 1996-10-23 under 510(k) number K962944. 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 TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)?

TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) is a medical device that received FDA 510(k) clearance on 1996-10-23. The listed applicant is Transtracheal Systems. The 510(k) number is K962944.

When did TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) receive FDA 510(k) clearance?

TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) received FDA 510(k) clearance on 1996-10-23, under 510(k) number K962944.

Who is the listed applicant for TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)?

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

What is the FDA product code for TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)?

The FDA product code for TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) is NFB.

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Other records listing Transtracheal Systems 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.

K982943TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000K981078TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000K981080SCOOP 1K904748TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100K904749TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200K902281MODIFIED SCOOP TRANSTRACHEAL CATHETERS

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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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter LabsK131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, LLC

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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