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FDA 510(k)

MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA

K-Number: K863883 · 1986-10-27

ApplicantSalter Labs
Decision Date1986-10-27
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1986-10-27 under 510(k) number K863883. 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 MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA?

MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA is a medical device that received FDA 510(k) clearance on 1986-10-27. The listed applicant is Salter Labs. The 510(k) number is K863883.

When did MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA receive FDA 510(k) clearance?

MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA received FDA 510(k) clearance on 1986-10-27, under 510(k) number K863883.

Who is the listed applicant for MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA?

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 MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA?

The FDA product code for MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA 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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