The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Carestation 620/650/650c.
| Device ID | K151570 |
| 510k Number | K151570 |
| Device Name: | Carestation 620/650/650C |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX-OHMEDA, INC. 3030 OHMEDA DR. P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | James Raskob |
| Correspondent | James Raskob DATEX-OHMEDA, INC. 3030 OHMEDA DR. P.O. BOX 7550 Madison, WI 53707 -7550 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-10 |
| Decision Date | 2016-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103985 | K151570 | 000 |
| 00840682103954 | K151570 | 000 |
| 00840682103947 | K151570 | 000 |