FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421
K Number: K875308
·
Decision Feb 26, 1988
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
3
Review Days
59
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
- PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421
- K Number
- K875308
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Self Regulation Systems, Inc.
- Date Received
- December 29, 1987
- Decision Date
- February 26, 1988
- 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