The following data is part of a premarket notification filed by Natus Medical, Inc. with the FDA for Natus Blue Light Phototherapy Unit.
| Device ID | K022196 |
| 510k Number | K022196 |
| Device Name: | NATUS BLUE LIGHT PHOTOTHERAPY UNIT |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Sheila Ramerman |
| Correspondent | Sheila Ramerman NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-05 |
| Decision Date | 2002-09-19 |
| Summary: | summary |