The following data is part of a premarket notification filed by Sunrise Medical Hhg, Inc. with the FDA for Devilbiss Suction Unit.
| Device ID | K982304 |
| 510k Number | K982304 |
| Device Name: | DEVILBISS SUCTION UNIT |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Matt Smith |
| Correspondent | Matt Smith SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-01 |
| Decision Date | 1998-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885304032564 | K982304 | 000 |
| 00885304002345 | K982304 | 000 |
| 00885304002338 | K982304 | 000 |
| 00885304000990 | K982304 | 000 |
| 00885304000815 | K982304 | 000 |
| 00885304000617 | K982304 | 000 |
| 00885304000600 | K982304 | 000 |
| 00885304000594 | K982304 | 000 |
| 00885304000587 | K982304 | 000 |
| 00885304000549 | K982304 | 000 |
| 00885304000532 | K982304 | 000 |
| 00885304000525 | K982304 | 000 |
| 00885304000518 | K982304 | 000 |
| 00885304000501 | K982304 | 000 |
| 00885304000495 | K982304 | 000 |
| 00885304000327 | K982304 | 000 |
| 00885304002352 | K982304 | 000 |
| 00885304002369 | K982304 | 000 |
| 00885304002376 | K982304 | 000 |
| 00885304032540 | K982304 | 000 |
| 00885304022312 | K982304 | 000 |
| 00885304022305 | K982304 | 000 |
| 00885304022299 | K982304 | 000 |
| 00885304022282 | K982304 | 000 |
| 00885304008897 | K982304 | 000 |
| 00885304008880 | K982304 | 000 |
| 00885304008873 | K982304 | 000 |
| 00885304008866 | K982304 | 000 |
| 00885304002994 | K982304 | 000 |
| 00885304002543 | K982304 | 000 |
| 00885304002420 | K982304 | 000 |
| 00885304002413 | K982304 | 000 |
| 00885304002390 | K982304 | 000 |
| 00885304002383 | K982304 | 000 |
| 00853040023382 | K982304 | 000 |