Flotec Oxysavrr (S)
FDA 510(k)Class II (US FDA 510(k))
by Flotec, Inc.
Identifiers
- 510(k) Number
- K970371 FDA 510(k)
- FDA Product Code
- NFB 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 Flotec Oxysavrr (S) is an oxygen conserving device, classified under the nomenclature for conservers and oxygen delivery systems. It is designed to optimize oxygen flow by monitoring a patient’s breathing cycle, reducing waste during exhalation and pauses, and automatically restarting flow during inhalation. This device functions as an accessory to oxygen delivery systems, ensuring efficient oxygen administration for patients with chronic obstructive pulmonary disease (COPD).
The Flotec Oxysavrr (S) is intended for use in clinical settings where precise oxygen delivery is required. It is a single-use device, supplied sterile, and falls under product code NFB with a regulatory classification as Class II under special controls. Authorized by an FDA 510(k) clearance (K970371) in 1997, it adheres to U.S. regulatory standards for conserving oxygen systems. Storage and handling follow standard sterile medical device protocols.
Frequently asked questions
What is the Flotec Oxysavrr (S) designed to do?
The Flotec Oxysavrr (S) is an oxygen conserving device that optimizes oxygen flow by monitoring a patient’s breathing cycle. It reduces unnecessary oxygen delivery during exhalation and pauses, then automatically restarts flow during inhalation. This ensures efficient oxygen administration, particularly for patients with chronic obstructive pulmonary disease (COPD).
Is the Flotec Oxysavrr (S) single-use or reusable?
The Flotec Oxysavrr (S) is a single-use device. It is supplied sterile and intended for one-time use per patient, adhering to standard sterile medical device protocols for handling and storage.
How is the Flotec Oxysavrr (S) regulated in the U.S.?
The Flotec Oxysavrr (S) holds an FDA 510(k) clearance (K970371) and is classified under product code NFB as a Class II device under special controls. It was authorized in 1997 and is intended for use as an accessory to oxygen delivery systems in clinical settings.
What storage and handling guidelines apply to the Flotec Oxysavrr (S)?
The Flotec Oxysavrr (S) must be stored and handled according to standard sterile medical device protocols. Since it is single-use and supplied sterile, it should remain unopened until immediate use and disposed of properly after use to maintain sterility and compliance with regulatory standards.
Can the Flotec Oxysavrr (S) be used with any oxygen delivery system?
The Flotec Oxysavrr (S) is designed as an accessory to oxygen delivery systems, specifically to enhance efficiency in delivering oxygen. While it is intended for use with compatible systems, compatibility should be confirmed with the manufacturer’s instructions to ensure proper function and safety.
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: FLOTEC OXYSAVRR (S) (K970371) — FDA 510 (k) | Innolitics, K970371 FDA 510 (k) - FLOTEC OXYSAVRR (S) | Flotec, Inc., Flotec, Inc. FDA 510 (k) Products (1990-1997), Oxysavrr Conserving Regulator Service Manual - studylib.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970371 | Class II | Active |
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Manufacturer
- Manufacturer
- Flotec, Inc.
Sources (1)
- FDA 510(k) K970371 24 fields · synced Oct 1, 2026