The following data is part of a premarket notification filed by Intersurgical Incorporated with the FDA for Facefit And Facefit Ported Non-invasive Ventilation Masks.
| Device ID | K121747 |
| 510k Number | K121747 |
| Device Name: | FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | INTERSURGICAL INCORPORATED 417 ELECTRONICS PARKWAY Liverpool, NY 13088 |
| Contact | Michael Zalewski |
| Correspondent | Michael Zalewski INTERSURGICAL INCORPORATED 417 ELECTRONICS PARKWAY Liverpool, NY 13088 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-14 |
| Decision Date | 2013-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267128273 | K121747 | 000 |
| 05030267128259 | K121747 | 000 |
| 05030267128235 | K121747 | 000 |
| 05030267089680 | K121747 | 000 |