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FDA 510(k)

CPAP SYSTEM, MODEL 102001

K-Number: K001318 · 2000-07-20

ApplicantSims Portex, Inc.
Decision Date2000-07-20
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPAP SYSTEM, MODEL 102001 is the device name listed in this FDA 510(k) record. The listed applicant is Sims Portex, Inc.. It received FDA 510(k) clearance on 2000-07-20 under 510(k) number K001318. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPAP SYSTEM, MODEL 102001?

CPAP SYSTEM, MODEL 102001 is a medical device that received FDA 510(k) clearance on 2000-07-20. The listed applicant is Sims Portex, Inc.. The 510(k) number is K001318.

When did CPAP SYSTEM, MODEL 102001 receive FDA 510(k) clearance?

CPAP SYSTEM, MODEL 102001 received FDA 510(k) clearance on 2000-07-20, under 510(k) number K001318.

Who is the listed applicant for CPAP SYSTEM, MODEL 102001?

The FDA 510(k) record lists Sims Portex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPAP SYSTEM, MODEL 102001?

The FDA product code for CPAP SYSTEM, MODEL 102001 is BYE.

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Other records listing Sims Portex, Inc. as applicant

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Related Devices (Code: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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