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DPAP Stealth Sleepnet Model 84000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K962713

by Sleepnet Corporation

Identifiers

510(k) Number
K962713 FDA 510(k)
FDA Product Code
BZD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5905 FDA 510(k)
Regulation Number
868.5905 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The DPAP Stealth Sleepnet Model 84000 is a ventilator, non-continuous (respirator), designed to assist or control patient ventilation during anesthesia procedures. It delivers pressure support to maintain adequate oxygenation and ventilation in patients under sedation or general anesthesia, ensuring respiratory support in controlled environments such as operating rooms or procedural suites.

This device is intended for use in clinical settings by trained healthcare professionals, specifically within the specialty of anesthesiology. Supplied as a reusable medical device, it is regulated under FDA classification II (868.5905) and holds a 510(k) clearance (K962713) for substantial equivalence. The device requires proper maintenance, calibration, and adherence to manufacturer guidelines to ensure safe and effective operation.

Frequently asked questions

What is the primary clinical use for the DPAP Stealth Sleepnet Model 84000, and who should operate it?

The DPAP Stealth Sleepnet Model 84000 is designed as a non-continuous ventilator (respirator) to assist or control patient ventilation during anesthesia procedures. It delivers pressure support to maintain adequate oxygenation and ventilation in patients under sedation or general anesthesia. This device is intended for use in controlled environments like operating rooms or procedural suites, and it should only be operated by trained healthcare professionals specializing in anesthesiology.

Is the DPAP Stealth Sleepnet Model 84000 a single-use or reusable device, and what maintenance is required?

The DPAP Stealth Sleepnet Model 84000 is a reusable medical device. To ensure safe and effective operation, it requires proper maintenance, calibration, and adherence to the manufacturer’s guidelines, which should be followed strictly by trained personnel.

How is the regulatory status of this device determined, and what does that mean for purchasing or use?

The DPAP Stealth Sleepnet Model 84000 holds an FDA 510(k) clearance (K962713) under classification II (868.5905), meaning it has been determined to be substantially equivalent to a legally marketed device. This clearance indicates that the device meets FDA requirements for safety and effectiveness as intended for use in assisting or controlling ventilation during anesthesia procedures. Purchasers should confirm compliance with the manufacturer’s instructions and maintenance protocols to ensure proper operation.

Are there multiple models or configurations of this device, and how can I identify the correct one for my needs?

The DPAP Stealth Sleepnet Model 84000 is listed with multiple registration numbers (e.g., 3030970580, 3010440667), which may correspond to different configurations or facility-specific registrations. However, the core specifications and intended use remain consistent across these registrations. To ensure compatibility, verify the model number (84000) and consult the manufacturer’s documentation or your facility’s existing inventory to confirm the correct version for your clinical setting.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DPAP STEALTH SLEEPNET MODEL NUMBER 84000 (K962713) — FDA 510 (k ..., Dpap Stealth Sleepnet Model Number 84000 - Beudamed, DPAP STEALTH SLEEPNET MODEL NUMBER 84000 (K962713) — FDA 510 (k ..., Dpap Stealth Sleepnet Model Number 84000 510 (k) FDA Premarket ..., SLEEPNET CORPORATION FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sleepnet Corporation

Sources (1)

  • FDA 510(k) K962713 24 fields · synced Sep 19, 2026