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FDA 510(k)

SLEEPNET HUMIDIFIER,(84200 PACKAGED)

K-Number: K963025 · 1996-11-01

ApplicantSleepnet Corporation
Decision Date1996-11-01
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPNET HUMIDIFIER,(84200 PACKAGED) is the device name listed in this FDA 510(k) record. The listed applicant is Sleepnet Corporation. It received FDA 510(k) clearance on 1996-11-01 under 510(k) number K963025. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEPNET HUMIDIFIER,(84200 PACKAGED)?

SLEEPNET HUMIDIFIER,(84200 PACKAGED) is a medical device that received FDA 510(k) clearance on 1996-11-01. The listed applicant is Sleepnet Corporation. The 510(k) number is K963025.

When did SLEEPNET HUMIDIFIER,(84200 PACKAGED) receive FDA 510(k) clearance?

SLEEPNET HUMIDIFIER,(84200 PACKAGED) received FDA 510(k) clearance on 1996-11-01, under 510(k) number K963025.

Who is the listed applicant for SLEEPNET HUMIDIFIER,(84200 PACKAGED)?

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

What is the FDA product code for SLEEPNET HUMIDIFIER,(84200 PACKAGED)?

The FDA product code for SLEEPNET HUMIDIFIER,(84200 PACKAGED) is BTT.

Related Clinical Trials

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.

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Other records listing Sleepnet Corporation 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.

K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskK241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented MaskK241943Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented MaskK241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskK241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented MaskK241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask

View all 23 devices →

Related Devices (Code: BTT)

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.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

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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