The following data is part of a premarket notification filed by Draeger Medical Gmbh with the FDA for Perseus A500.
| Device ID | K133886 |
| 510k Number | K133886 |
| Device Name: | PERSEUS A500 |
| Classification | Gas-machine, Anesthesia |
| Applicant | DRAEGER MEDICAL GMBH 6 TECH DRIVE Andover, MA 01810 |
| Contact | Beth Zis |
| Correspondent | Beth Zis DRAEGER MEDICAL GMBH 6 TECH DRIVE Andover, MA 01810 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675253600 | K133886 | 000 |