The following data is part of a premarket notification filed by E & B Technologies, Inc. with the FDA for Precious Lite Model 4224.
| Device ID | K892940 |
| 510k Number | K892940 |
| Device Name: | PRECIOUS LITE MODEL 4224 |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | E & B TECHNOLOGIES, INC. 4035 OCEANSIDE BLVD-C-16 P.O. BOX 6377 Oceanside, CA 92056 |
| Contact | John Erickson |
| Correspondent | John Erickson E & B TECHNOLOGIES, INC. 4035 OCEANSIDE BLVD-C-16 P.O. BOX 6377 Oceanside, CA 92056 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-21 |
| Decision Date | 1989-08-03 |