The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Babytherm 8000 Wb.
| Device ID | K945467 |
| 510k Number | K945467 |
| Device Name: | BABYTHERM 8000 WB |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | DRAGER, INC. 100-4101 P[LEASANT VALLEY RD. Chantilly, VA 22021 |
| Contact | Harald Kneuer |
| Correspondent | Harald Kneuer DRAGER, INC. 100-4101 P[LEASANT VALLEY RD. Chantilly, VA 22021 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-07 |
| Decision Date | 1995-04-28 |