The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Suctioneasy.
| Device ID | K882017 |
| 510k Number | K882017 |
| Device Name: | RESPIRONICS SUCTIONEASY |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Eugene N Scarberry |
| Correspondent | Eugene N Scarberry RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-13 |
| Decision Date | 1988-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860007555326 | K882017 | 000 |
| 00860007555329 | K882017 | 000 |
| 00860007555336 | K882017 | 000 |