The following data is part of a premarket notification filed by Lumitex, Inc. with the FDA for Giraffe Blue Spot Pt Lite.
| Device ID | K120820 |
| 510k Number | K120820 |
| Device Name: | GIRAFFE BLUE SPOT PT LITE |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | LUMITEX, INC. 8443 DOW CIR. Strongsville, OH 44136 |
| Contact | David Felty |
| Correspondent | David Felty LUMITEX, INC. 8443 DOW CIR. Strongsville, OH 44136 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682116572 | K120820 | 000 |
| 00840682116541 | K120820 | 000 |