The following data is part of a premarket notification filed by Heraeus Med Gmbh with the FDA for Hanaulux Blue 80 Hospital.
| Device ID | K970886 |
| 510k Number | K970886 |
| Device Name: | HANAULUX BLUE 80 HOSPITAL |
| Classification | Light, Surgical, Floor Standing |
| Applicant | HERAEUS MED GMBH HERAEUSSTRASSE 12-14 Hanau, DE D-63450 |
| Contact | Mark Schulz |
| Correspondent | Mark Schulz HERAEUS MED GMBH HERAEUSSTRASSE 12-14 Hanau, DE D-63450 |
| Product Code | FSS |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-06 |
| Decision Date | 1997-04-16 |
| Summary: | summary |