FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDI-TRACE EEG CREME
K Number: K790818
·
Decision Jun 5, 1979
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
68
Applicant Total
55
Review Days
39
Basic Information
- Device Name
- MEDI-TRACE EEG CREME
- K Number
- K790818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- GRAPHIC CONTROLS CORP.
- Date Received
- April 27, 1979
- Decision Date
- June 5, 1979
- Product Code
- GYB
- 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
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| K972970 | MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | Aug 27, 1997 | Substantially Equivalent |
| K964387 | POINT OF USE II SHARPS-A-GATOR | Mar 27, 1997 | Substantially Equivalent |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | Jan 22, 1997 | Substantially Equivalent |
| K963151 | MEDI-TRACE 5700 RESTING ECG ELECTRODE | Nov 19, 1996 | Substantially Equivalent |
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| K960968 | MEDI-TRACE 200, MEDI-TRACE 200-30 | Oct 28, 1996 | Substantially Equivalent |