FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
HR/BVP 100T HEART RATE MONITOR
K Number: K850643
·
Decision May 17, 1985
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
22
Review Days
87
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HR/BVP 100T HEART RATE MONITOR
- K Number
- K850643
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Thought Technology , Ltd.
- Date Received
- February 19, 1985
- Decision Date
- May 17, 1985
- Product Code
- HCC
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HCC), ordered by most recent decision date.
A Breathing System (ABS)
FDA 510(k)
FDA Class 2
·Neurology
Prism
FDA 510(k)
FDA Class 2
·Neurology
Freespira
FDA 510(k)
FDA Class 2
·Neurology
GrindCare System
FDA 510(k)
FDA Class 2
·Neurology
Pacifier Activated Lullaby (PAL®)
FDA 510(k)
FDA Class 2
·Neurology
NFANT Feeding Solution
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Thought Technology , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K213197 | MyOnyx System | Jun 17, 2022 | Substantially Equivalent |
| K201014 | MyOnyx System | Jan 13, 2021 | Substantially Equivalent |
| K053434 | MYOTRAC INFINITI ELECTRICAL STIMULATOR | Mar 15, 2006 | Substantially Equivalent |
| K053266 | MYOTRAC INFINITI | Dec 29, 2005 | Substantially Equivalent |
| K925681 | MYOTRAC2D/CS | Sep 29, 1995 | Substantially Equivalent |
| K932149 | THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE | May 11, 1995 | Substantially Equivalent |
| K935213 | INCONTROL | May 11, 1995 | Substantially Equivalent |
| K915858 | MYOTRAC2 | Sep 9, 1992 | Substantially Equivalent |
| K915859 | MYOTRAC/S, MYODAC/S | Sep 9, 1992 | Substantially Equivalent |
| K913898 | MYOTRAC+/S, MYODAC+/S | Mar 26, 1992 | Substantially Equivalent |