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FDA 510(k)

OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES

K-Number: K881663 · 1988-08-19

ApplicantSalter Labs
Decision Date1988-08-19
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1988-08-19 under 510(k) number K881663. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES?

OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES is a medical device that received FDA 510(k) clearance on 1988-08-19. The listed applicant is Salter Labs. The 510(k) number is K881663.

When did OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES receive FDA 510(k) clearance?

OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES received FDA 510(k) clearance on 1988-08-19, under 510(k) number K881663.

Who is the listed applicant for OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES?

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 OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES?

The FDA product code for OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES is CCL.

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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: CCL)

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)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, 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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