The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Aespire View.
| Device ID | K143530 |
| 510k Number | K143530 |
| Device Name: | Aespire View |
| Classification | Gas-machine, Anesthesia |
| Applicant | Datex-Ohmeda, Inc. 3030 Ohmeda Drive P.O.Box7550 Madison, WI 53707 |
| Contact | Michelle Huettner |
| Correspondent | Michelle Huettner Datex-Ohmeda, Inc. 3030 Ohmeda Drive P.O.Box7550 Madison, WI 53707 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-12 |
| Decision Date | 2015-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682102285 | K143530 | 000 |