The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Reusable Contour Ii Nasal Mask.
| Device ID | K991648 |
| 510k Number | K991648 |
| Device Name: | REUSABLE CONTOUR II NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | David J Vanella |
| Correspondent | David J Vanella RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-13 |
| Decision Date | 1999-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30606959000743 | K991648 | 000 |
| 00606959023161 | K991648 | 000 |
| 40606959024807 | K991648 | 000 |
| 40606959024814 | K991648 | 000 |
| 30606959024824 | K991648 | 000 |
| 30606959024831 | K991648 | 000 |
| 30606959024848 | K991648 | 000 |
| 30606959024855 | K991648 | 000 |
| 30606959024862 | K991648 | 000 |
| 30606959024879 | K991648 | 000 |
| 30606959024886 | K991648 | 000 |
| 40606959000733 | K991648 | 000 |
| 00606959023154 | K991648 | 000 |