The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Ge Datex-ohmeda Aisys Cs2 (aisys Cs^2).
| Device ID | K132530 |
| 510k Number | K132530 |
| Device Name: | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX-OHMEDA, INC. 3030 Ohmeda Dr Madison, WI 53718 |
| Contact | James P Raskob |
| Correspondent | James P Raskob DATEX-OHMEDA, INC. 3030 Ohmeda Dr Madison, WI 53718 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682102292 | K132530 | 000 |
| 00840682100212 | K132530 | 000 |
| 00840682100229 | K132530 | 000 |
| 00840682100236 | K132530 | 000 |
| 00840682100243 | K132530 | 000 |
| 00840682100250 | K132530 | 000 |
| 00840682100267 | K132530 | 000 |
| 00840682100274 | K132530 | 000 |
| 00840682100281 | K132530 | 000 |
| 00840682100298 | K132530 | 000 |
| 00840682100205 | K132530 | 000 |