Hr/Bvp 100T Heart Rate Monitor
FDA 510(k) K850643 · Thought Technology , Ltd.
510(k) numberK850643
Submission
- Device name
- Hr/Bvp 100T Heart Rate Monitor
- Applicant
- Thought Technology , Ltd.
Montreal, Quebec, CA - Received
- February 19, 1985
- Decision date
- May 17, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K233580 | A Breathing System (ABS)HCC · Traditional | Deepwell Dtx, Inc. | 08/01/2024SE |
| K222101 | PrismHCC · Traditional | Graymatters Health , Ltd. | 03/17/2023SE |
| K180173 | FreespiraHCC · Traditional | Palo Alto Health Sciences, Inc. | 08/23/2018SE |
| 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 |
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| K915859 | Myotrac/S, Myodac/SHCC · Traditional | 09/09/1992SE |
| K915858 | MYOTRAC2HCC · Traditional | 09/09/1992SE |
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Questions and answers
When was Hr/Bvp 100T Heart Rate Monitor cleared by the FDA?
Hr/Bvp 100T Heart Rate Monitor (K850643) received a 510(k) decision of Substantially Equivalent on May 17, 1985, 87 days after the submission was received.
What is the product code of K850643?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.