FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIFE TRACE(R) BILIRUBIN MASK
K Number: K926118
·
Decision Mar 15, 1993
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
4
Applicant Total
55
Review Days
102
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Basic Information
- Device Name
- LIFE TRACE(R) BILIRUBIN MASK
- K Number
- K926118
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5270
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Graphic Controls Corp.
- Date Received
- December 3, 1992
- Decision Date
- March 15, 1993
- Product Code
- FOK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOK | Pad, Neonatal Eye | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOK), ordered by most recent decision date.
DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
FDA 510(k)
FDA Class 1
·General Hospital
INFANT PHOTOTHERAPY MASK
FDA 510(k)
FDA Class 1
·General Hospital
PHOTO-THERAPY EYE PROTECTOR
FDA 510(k)
FDA Class 1
·General Hospital
INFANT PHOTOTHERAPY MASK
FDA 510(k)
FDA Class 1
·General Hospital
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 |