Freespira
FDA 510(k) K180173 · Palo Alto Health Sciences, Inc.
510(k) numberK180173
Submission
- Device name
- Freespira
- Applicant
- Palo Alto Health Sciences, Inc.
Kirkland, WA, US - Received
- January 22, 2018
- Decision date
- August 23, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HCC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233580 | A Breathing System (ABS)HCC · Traditional | Deepwell Dtx, Inc. | 08/01/2024SE |
| K222101 | PrismHCC · Traditional | Graymatters Health , Ltd. | 03/17/2023SE |
| K163448 | GrindCare SystemHCC · Traditional | Sunstar Suisse S.A. | 09/01/2017SE |
| K151050 | Pacifier Activated Lullaby (PAL®)HCC · Traditional | Power Medical Devices, LLC | 12/22/2015SE |
| K143507 | NFANT Feeding SolutionHCC · Traditional | Nfant Labs, LLC | 09/09/2015SE |
| K131586 | Canary Breathing SystemHCC · Traditional | Palo Alto Health Sciences, Inc. | 12/10/2013SE |
| K122879 | EEGER4 Model 4.3HCC · Traditional | Eeg Software, LLC | 02/06/2013SE |
| K111687 | Emg SystemHCC · Special | Myotronics-Noromed, Inc. | 09/29/2011SE |
| K092675 | GrindcareHCC · Traditional | Medotech A/S | 03/03/2010SE |
| K073557 | EEG Neuroamp, Model CS10137HCC · Traditional | Corscience GmbH & Co. KG | 02/28/2008SE |
More from Corscience GmbH & Co. KG
| 510(k) | Device | Decision |
|---|---|---|
| K131586 | Canary Breathing SystemHCC · Traditional | 12/10/2013SE |
Questions and answers
When was Freespira cleared by the FDA?
Freespira (K180173) received a 510(k) decision of Substantially Equivalent on August 23, 2018, 213 days after the submission was received.
What is the product code of K180173?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.