FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
RHYTHM
K Number: K912938
·
Decision Jul 30, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
7
Review Days
25
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Basic Information
- Device Name
- RHYTHM
- K Number
- K912938
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1420
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stellate Systems
- Date Received
- July 5, 1991
- Decision Date
- July 30, 1991
- Product Code
- GWS
- 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 |
|---|---|---|---|
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | FDA class 1 | Neurology |
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| K982351 | LUNA | Jul 29, 1998 | Substantially Equivalent |
| K955577 | ECLIPSE VERSION 3.0 | Sep 20, 1996 | Substantially Equivalent |
| K960273 | HARMONIE SENSA | Apr 4, 1996 | Substantially Equivalent |