Datex-Ohmeda TuffSat 3000 Pulse Oximeter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K993512 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Datex-Ohmeda TuffSat 3000 Pulse Oximeter is a handheld, non-invasive device designed for measuring oxygen saturation (SpO₂) and pulse rate. Classified as a pulse oximeter, it provides real-time monitoring of vital signs through photoplethysmographic technology, enabling quick assessment of patient oxygenation levels in various clinical settings.
This device operates on four 1.5V alkaline AA batteries and is intended for single-use or reusable applications in settings such as respiratory care, hospital satellite facilities, doctor’s offices, transport, and emergency medical services. Supplied as a portable unit, it adheres to FDA 510(k) clearance (K993512) under the Special 510(k) pathway, with no explicit sterility or MRI safety requirements stated. Storage and handling follow standard battery-powered medical device protocols.
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: GE Datex Ohmeda TuffSat Pulse Oximeter - Soma Tech Intl, Datex-Ohmeda TuffSat User's Manual And Service Manual, DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER (K993512) — FDA 510 (k ..., GE TUFFSAT USER'S MANUAL AND SERVICE MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993512 | Class II | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- FDA Applicant
- Datex-Ohmeda, Inc.
Sources (1)
- FDA 510(k) K993512 24 fields · synced Sep 19, 2026