510(k) K912747
K912747 is an FDA 510(k) premarket notification submitted by Lumitex, Inc. for the device "LULMITEX NEONATAL TRANSILLUMINATOR". The FDA issued a decision of Substantially Equivalent on December 24, 1991. The device falls under product code HJN (Transilluminator, Battery-Powered), a Class I device regulated under 21 CFR 886.1945. Lumitex, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 1991
- Date Received
- June 21, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transilluminator, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.1945
- Review Panel
- OP
- Submission Type