FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
TOENNIES NEUROSCREEN SYSTEM
K Number: K972419
·
Decision Apr 30, 1998
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
28
Review Days
307
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Basic Information
- Device Name
- TOENNIES NEUROSCREEN SYSTEM
- K Number
- K972419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Erich Jaeger, Inc.
- Date Received
- June 27, 1997
- Decision Date
- April 30, 1998
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
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|---|---|---|---|
| K000396 | APNOESCREEN PRO, ALPHA SCREEN PRO | Dec 27, 2000 | Substantially Equivalent |
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| K932744 | FLOWSCREEN | Mar 7, 1994 | Substantially Equivalent |
| K853443 | ALVEO-DIFFUSION TEST | Feb 21, 1986 | Substantially Equivalent |
| K853409 | SCREENMATE | Feb 5, 1986 | Substantially Equivalent |
| K853390 | INFANT BODY TEST | Feb 5, 1986 | Substantially Equivalent |
| K853434 | ERGO-PNEUMOTEST | Feb 5, 1986 | Substantially Equivalent |
| K853360 | N20 TEST | Sep 3, 1985 | Substantially Equivalent |
| K852337 | PNEUMOSCOPE | Jul 1, 1985 | Substantially Equivalent |