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FDA 510(k)

MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.

K-Number: K864902 · 1987-01-28

ApplicantSalter Labs
Decision Date1987-01-28
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU. is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1987-01-28 under 510(k) number K864902. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.?

MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU. is a medical device that received FDA 510(k) clearance on 1987-01-28. The listed applicant is Salter Labs. The 510(k) number is K864902.

When did MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU. receive FDA 510(k) clearance?

MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU. received FDA 510(k) clearance on 1987-01-28, under 510(k) number K864902.

Who is the listed applicant for MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.?

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

What is the FDA product code for MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.?

The FDA product code for MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU. is CCK.

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Other records listing Salter Labs 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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)K161719Salter Labs Bubble HumidifierK151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaK151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesK092685PNEUMOTHERML, MODEL: 5800

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Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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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