The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Spectrum 2 Reusable Full Face Mask, Model 1004884 And 1004876.
| Device ID | K002465 |
| 510k Number | K002465 |
| Device Name: | SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 |
| 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 | 2000-08-11 |
| Decision Date | 2000-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959014893 | K002465 | 000 |
| 30606959000651 | K002465 | 000 |
| 30606959000644 | K002465 | 000 |
| 30606959000637 | K002465 | 000 |
| 00606959041806 | K002465 | 000 |
| 00606959041790 | K002465 | 000 |
| 00606959041783 | K002465 | 000 |
| 30606959028389 | K002465 | 000 |
| 30606959028372 | K002465 | 000 |
| 30606959028365 | K002465 | 000 |
| 30606959028358 | K002465 | 000 |
| 30606959028341 | K002465 | 000 |
| 30606959028334 | K002465 | 000 |
| 30606959027672 | K002465 | 000 |
| 30606959027665 | K002465 | 000 |
| 00606959000667 | K002465 | 000 |
| 00606959000674 | K002465 | 000 |
| 00606959000681 | K002465 | 000 |
| 00606959014886 | K002465 | 000 |
| 00606959014879 | K002465 | 000 |
| 00606959009448 | K002465 | 000 |
| 00606959009431 | K002465 | 000 |
| 00606959009424 | K002465 | 000 |
| 30606959007599 | K002465 | 000 |
| 30606959007582 | K002465 | 000 |
| 30606959007575 | K002465 | 000 |
| 00606959004245 | K002465 | 000 |
| 00606959004238 | K002465 | 000 |
| 00606959004221 | K002465 | 000 |
| 30606959003294 | K002465 | 000 |
| 30606959003287 | K002465 | 000 |
| 30606959003270 | K002465 | 000 |
| 30606959027658 | K002465 | 000 |