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FDA 510(k)

OXYGEN CANNULA EAR WRAP (STYLE B)

K-Number: K863432 · 1986-09-18

ApplicantSalter Labs
Decision Date1986-09-18
Product CodeCAT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN CANNULA EAR WRAP (STYLE B) is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1986-09-18 under 510(k) number K863432. The device is classified under product code CAT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN CANNULA EAR WRAP (STYLE B)?

OXYGEN CANNULA EAR WRAP (STYLE B) is a medical device that received FDA 510(k) clearance on 1986-09-18. The listed applicant is Salter Labs. The 510(k) number is K863432.

When did OXYGEN CANNULA EAR WRAP (STYLE B) receive FDA 510(k) clearance?

OXYGEN CANNULA EAR WRAP (STYLE B) received FDA 510(k) clearance on 1986-09-18, under 510(k) number K863432.

Who is the listed applicant for OXYGEN CANNULA EAR WRAP (STYLE B)?

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 CANNULA EAR WRAP (STYLE B)?

The FDA product code for OXYGEN CANNULA EAR WRAP (STYLE B) is CAT.

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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: CAT)

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.

K011125NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCIHudson Respiratory Care, Inc.K935533NASAL CANNULAPuritas Health Care, Inc.K9223974 SURE TM NASAL OXYGEN CANNULABoston Pacific Medical, Inc.K921496SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIEDAlpine Specialties, Inc.K920573CANNULA NASAL OXYGENB & F Medical Products, Inc.K913421NASAL OXYGEN CANNULA, 81585, 81587 & 81589Specialty Packaging Producs, 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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