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FDA 510(k)

RESPIRONICS SLEEPEASY NASAL CPAP SYS

K-Number: K843889 · 1984-12-04

ApplicantRespironics, Inc.
Decision Date1984-12-04
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRONICS SLEEPEASY NASAL CPAP SYS is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1984-12-04 under 510(k) number K843889. 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 RESPIRONICS SLEEPEASY NASAL CPAP SYS?

RESPIRONICS SLEEPEASY NASAL CPAP SYS is a medical device that received FDA 510(k) clearance on 1984-12-04. The listed applicant is Respironics, Inc.. The 510(k) number is K843889.

When did RESPIRONICS SLEEPEASY NASAL CPAP SYS receive FDA 510(k) clearance?

RESPIRONICS SLEEPEASY NASAL CPAP SYS received FDA 510(k) clearance on 1984-12-04, under 510(k) number K843889.

Who is the listed applicant for RESPIRONICS SLEEPEASY NASAL CPAP SYS?

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

What is the FDA product code for RESPIRONICS SLEEPEASY NASAL CPAP SYS?

The FDA product code for RESPIRONICS SLEEPEASY NASAL CPAP SYS is BYE.

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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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