The following data is part of a premarket notification filed by Oricare, Inc. with the FDA for Critical Care Ventilator.
| Device ID | K120931 |
| 510k Number | K120931 |
| Device Name: | CRITICAL CARE VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | ORICARE, INC. 1900 AM DRIVE Quakertown, PA 18951 |
| Contact | David Jamison |
| Correspondent | David Jamison ORICARE, INC. 1900 AM DRIVE Quakertown, PA 18951 |
| Product Code | CBK |
| Subsequent Product Code | BTI |
| Subsequent Product Code | BTT |
| Subsequent Product Code | CCK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-27 |
| Decision Date | 2013-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815085020443 | K120931 | 000 |
| 00815085020320 | K120931 | 000 |
| 00815085020313 | K120931 | 000 |
| 00815085020306 | K120931 | 000 |
| 00815085020290 | K120931 | 000 |
| 00815085020283 | K120931 | 000 |
| 00815085020276 | K120931 | 000 |
| 00815085020269 | K120931 | 000 |
| 00815085020252 | K120931 | 000 |
| 00815085020245 | K120931 | 000 |
| 00815085020337 | K120931 | 000 |
| 00815085020344 | K120931 | 000 |
| 00815085020436 | K120931 | 000 |
| 00815085020429 | K120931 | 000 |
| 00815085020412 | K120931 | 000 |
| 00815085020405 | K120931 | 000 |
| 00815085020399 | K120931 | 000 |
| 00815085020382 | K120931 | 000 |
| 00815085020375 | K120931 | 000 |
| 00815085020368 | K120931 | 000 |
| 00815085020351 | K120931 | 000 |
| 00815085020238 | K120931 | 000 |