GE Datex-Ohmeda Aespire 7900 Anesthesia System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050626 FDA 510(k)
- FDA Product Code
- BSZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5160 FDA 510(k)
- Regulation Number
- 868.5160 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The GE Datex-Ohmeda Aespire 7900 Anesthesia System is a gas-machine anesthesia device designed for the delivery of anesthetic gases and ventilation support during surgical procedures. It is classified as a Class II medical device under FDA regulation number 868.5160 and was found substantially equivalent through the 510(k) clearance process.
The system is intended for use in clinical anesthesia settings and is supplied as a reusable anesthesia delivery system. It requires proper cleaning, maintenance, and calibration according to manufacturer guidelines. No information regarding sterility, single-use status, MRI safety, specific sizes, or storage conditions is provided in the supplied data.
Frequently asked questions
What is the GE Datex-Ohmeda Aespire 7900 Anesthesia System used for?
The GE Datex-Ohmeda Aespire 7900 Anesthesia System is designed for the delivery of anesthetic gases and ventilation support during surgical procedures in clinical anesthesia settings, as it is a gas-machine anesthesia device intended to maintain patient respiration and administer inhaled anesthetics safely throughout operations.
Is the GE Datex-Ohmeda Aespire 7900 Anesthesia System reusable or single-use?
The system is supplied as a reusable anesthesia delivery system, meaning it is intended for multiple uses after proper cleaning, maintenance, and calibration according to manufacturer guidelines, rather than being discarded after a single procedure.
How was the GE Datex-Ohmeda Aespire 7900 Anesthesia System cleared for market release?
The device was found substantially equivalent through the FDA 510(k) clearance process, specifically under regulation number 868.5160, with clearance type classified as Special, indicating it met the requirements for demonstrating substantial equivalence to a legally marketed predicate device.
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: Datex-Ohmeda Aespire 7900 Technical Reference Manual, Datex-Ohmeda Aespire 7900 User's Reference Manual, Datex-Ohmeda Aespire 7900 User's Reference Manual | Manualzz, PDF Datex-Ohmeda Aespire 7900 - Technical Reference Manual.pdf, PDF S/5 Aespire User s Reference Manual - Part 1
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050626 | Class II | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- FDA Applicant
- Datex-Ohmeda, Inc.
Sources (1)
- FDA 510(k) K050626 24 fields · synced Oct 1, 2026