The following data is part of a premarket notification filed by Oricare, Inc. with the FDA for A9800 Anesthesia Workstation.
| Device ID | K131790 |
| 510k Number | K131790 |
| Device Name: | A9800 ANESTHESIA WORKSTATION |
| Classification | Gas-machine, Anesthesia |
| Applicant | ORICARE, INC. 1900 AM DRIVE Quakertown, PA 18951 |
| Contact | Kurtis Montegna |
| Correspondent | Kurtis Montegna ORICARE, INC. 1900 AM DRIVE Quakertown, PA 18951 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-18 |
| Decision Date | 2014-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815085020221 | K131790 | 000 |
| 00815085020108 | K131790 | 000 |
| 00815085020092 | K131790 | 000 |
| 00815085020085 | K131790 | 000 |
| 00815085020078 | K131790 | 000 |
| 00815085020061 | K131790 | 000 |
| 00815085020054 | K131790 | 000 |
| 00815085020047 | K131790 | 000 |
| 00815085020030 | K131790 | 000 |
| 00815085020023 | K131790 | 000 |
| 00815085020115 | K131790 | 000 |
| 00815085020122 | K131790 | 000 |
| 00815085020214 | K131790 | 000 |
| 00815085020207 | K131790 | 000 |
| 00815085020191 | K131790 | 000 |
| 00815085020184 | K131790 | 000 |
| 00815085020177 | K131790 | 000 |
| 00815085020160 | K131790 | 000 |
| 00815085020153 | K131790 | 000 |
| 00815085020146 | K131790 | 000 |
| 00815085020139 | K131790 | 000 |
| 00815085020016 | K131790 | 000 |