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FDA 510(k)

SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

K-Number: K962492 · 1997-01-23

ApplicantNidek Medical Products, Inc.
Decision Date1997-01-23
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Medical Products, Inc.. It received FDA 510(k) clearance on 1997-01-23 under 510(k) number K962492. 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 SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM?

SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-23. The listed applicant is Nidek Medical Products, Inc.. The 510(k) number is K962492.

When did SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM receive FDA 510(k) clearance?

SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM received FDA 510(k) clearance on 1997-01-23, under 510(k) number K962492.

Who is the listed applicant for SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM?

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

What is the FDA product code for SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM?

The FDA product code for SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM 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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