The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Whisper Swivel Ii Exhalation Port.
| Device ID | K962203 |
| 510k Number | K962203 |
| Device Name: | WHISPER SWIVEL II EXHALATION PORT |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Francis X Dobscha |
| Correspondent | Francis X Dobscha RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-07 |
| Decision Date | 1996-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959015166 | K962203 | 000 |
| 00606959020177 | K962203 | 000 |