510(k) K926118
K926118 is an FDA 510(k) premarket notification submitted by Graphic Controls Corp. for the device "LIFE TRACE(R) BILIRUBIN MASK". The FDA issued a decision of Substantially Equivalent on March 15, 1993. The device falls under product code FOK (Pad, Neonatal Eye), a Class I device regulated under 21 CFR 880.5270. Graphic Controls Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1993
- Date Received
- December 3, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Neonatal Eye
- Device Class
- Class I
- Regulation Number
- 880.5270
- Review Panel
- HO
- Submission Type