FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDI-TRACE THERMAL VIDEO FILM PAPER
K Number: K891192
·
Decision Apr 6, 1989
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
55
Review Days
31
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Basic Information
- Device Name
- MEDI-TRACE THERMAL VIDEO FILM PAPER
- K Number
- K891192
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Graphic Controls Corp.
- Date Received
- March 6, 1989
- Decision Date
- April 6, 1989
- Product Code
- LMD
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | Radiology |
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Other Clearances by Graphic Controls Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981964 | MEDI-TRACE 4103 NEONATAL ELECTRODE | Nov 13, 1998 | Substantially Equivalent |
| K983287 | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | Nov 5, 1998 | Substantially Equivalent |
| K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) | Jul 14, 1998 | Substantially Equivalent |
| K980857 | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE | May 12, 1998 | Substantially Equivalent |
| 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 |
| K963038 | MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE | Nov 15, 1996 | Substantially Equivalent |
| K960968 | MEDI-TRACE 200, MEDI-TRACE 200-30 | Oct 28, 1996 | Substantially Equivalent |