FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DUAL GRAPH (TM) RECORDER-MONITOR
K Number: K890711
·
Decision Jun 2, 1989
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
86
Applicant Total
7
Review Days
109
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Basic Information
- Device Name
- DUAL GRAPH (TM) RECORDER-MONITOR
- K Number
- K890711
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Somatics, Inc.
- Date Received
- February 13, 1989
- Decision Date
- June 2, 1989
- Product Code
- DSF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSF | Recorder, Paper Chart | FDA class 1 | Cardiovascular |
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Other Clearances by Somatics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992269 | VENTIL-A ORAL PROTECTOR | Oct 25, 1999 | Substantially Equivalent |
| K945120 | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM | Oct 26, 1995 | Substantially Equivalent |
| K890710 | DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS | Mar 14, 1989 | Substantially Equivalent |
| K882809 | THYMAPAD | Sep 27, 1988 | Substantially Equivalent |
| K864181 | SOMATICS MOUTH GUARD (BITE BLOCK) | Nov 3, 1986 | Substantially Equivalent |
| K843923 | THYMATRON | Dec 3, 1984 | Substantially Equivalent |