The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Drager Pt4000 Phototherapy System.
| Device ID | K954611 |
| 510k Number | K954611 |
| Device Name: | DRAGER PT4000 PHOTOTHERAPY SYSTEM |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | DRAGER, INC. 4101-100 PLEASANT VALLEY RD. Chantilly, VA 22021 |
| Contact | Harald Kneuer |
| Correspondent | Harald Kneuer DRAGER, INC. 4101-100 PLEASANT VALLEY RD. Chantilly, VA 22021 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-04 |
| Decision Date | 1995-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675246312 | K954611 | 000 |
| 04048675242376 | K954611 | 000 |