Sullivan Vpap II ST Ventilatory Support System
FDA 510(k) K974539 · Resmed, Ltd.
510(k) numberK974539
Submission
- Device name
- Sullivan Vpap II ST Ventilatory Support System
- Applicant
- Resmed, Ltd.
San Diego, CA, US - Received
- December 3, 1997
- Decision date
- August 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MNT – Sv70 Ventilator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K233643 | F&P Airvo 3 NIV (PT311US)MNT · Traditional | Fisher & Paykel Healthcare, Ltd. | 08/09/2024SE |
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| K213521 | Nihon Kohden NKV-330 Ventilator SystemMNT · Traditional | Nihon Kohden Orangemed, Inc. | 07/01/2022SE |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionMNT · Traditional | Fisher & Paykel Healthcare Limited | 03/09/2020SE |
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| K122715 | Stellar 150MNT · Traditional | Resmed Germany, Inc. | 06/17/2013SE |
| K121623 | BIPAP a 40 Ventilatory Support SystemMNT · Abbreviated | Respironics, Inc. | 12/14/2012SE |
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Questions and answers
When was Sullivan Vpap II ST Ventilatory Support System cleared by the FDA?
Sullivan Vpap II ST Ventilatory Support System (K974539) received a 510(k) decision of Substantially Equivalent on August 6, 1998, 246 days after the submission was received.
What is the product code of K974539?
The FDA product code is MNT – Sv70 Ventilator, a Class II (moderate risk) device regulated under 21 CFR 868.5895.