Astoflo Plus
FDA 510(k) K082765 · Stihler Electronic GmbH
510(k) numberK082765
Submission
- Device name
- Astoflo Plus
- Applicant
- Stihler Electronic GmbH
Sound Beach, NY, US - Received
- September 22, 2008
- Decision date
- December 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LGZ – Warmer, Thermal, Infusion Fluid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K192325 | Quantum Blood and Fluid Warming SystemLGZ · Special | Life Warmer, Inc. | 10/18/2019SE |
| K180842 | MAC Medical D-Series Blanket and Solution Warming CabinetsLGZ · Traditional | Mac Medical, Inc. | 03/05/2019SE |
More from Mac Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260278 | ThermAffyx(TM) Patient Safety SystemDWJ · Traditional | 07/08/2026SE |
| K202197 | Astopad Patient Warming SystemDWJ · Traditional | 09/04/2020SE |
| K082758 | Prismaflo IIKOC · Special | 12/19/2008SE |
| K020103 | PrismafloKOC · Abbreviated | 07/24/2002SE |
| K991159 | Prismatherm II, AstolineBSB · Abbreviated | 09/03/1999SE |
| K991160 | Astotherm Plus, Astotubes, AstolineBSB · Abbreviated | 09/02/1999SE |
Questions and answers
When was Astoflo Plus cleared by the FDA?
Astoflo Plus (K082765) received a 510(k) decision of Substantially Equivalent on December 18, 2008, 87 days after the submission was received.
What is the product code of K082765?
The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.