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FDA 510(k)

CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA

K-Number: K861758 · 1986-07-14

ApplicantLife Design Systems, Inc.
Decision Date1986-07-14
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA is the device name listed in this FDA 510(k) record. The listed applicant is Life Design Systems, Inc.. It received FDA 510(k) clearance on 1986-07-14 under 510(k) number K861758. 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 CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA?

CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA is a medical device that received FDA 510(k) clearance on 1986-07-14. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K861758.

When did CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA receive FDA 510(k) clearance?

CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA received FDA 510(k) clearance on 1986-07-14, under 510(k) number K861758.

Who is the listed applicant for CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA?

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

What is the FDA product code for CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA?

The FDA product code for CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA is BYE.

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Other records listing Life Design Systems, Inc. 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.

K913714MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)K885313HUMIDI-FLEX TMK893030CHILD SIZE - FILTER FLEX (TM)K892862FLEX-CUP PERCUSSORK892221PULMONARY RESUSCITATOR, MODIFICATIONK890011OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING

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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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