The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Model 780.
| Device ID | K031383 |
| 510k Number | K031383 |
| Device Name: | MODEL 780 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Contact | Charles Mierkiewicz |
| Correspondent | Charles Mierkiewicz HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-01 |
| Decision Date | 2003-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704660388 | K031383 | 000 |
| 24026704398472 | K031383 | 000 |
| 24026704398465 | K031383 | 000 |
| 24026704398458 | K031383 | 000 |
| 24026704398441 | K031383 | 000 |
| 24026704398434 | K031383 | 000 |
| 24026704660289 | K031383 | 000 |
| 24026704660265 | K031383 | 000 |
| 24026704660258 | K031383 | 000 |
| 24026704660234 | K031383 | 000 |
| 24026704558821 | K031383 | 000 |
| 24026704598117 | K031383 | 000 |
| 24026704660357 | K031383 | 000 |
| 24026704660340 | K031383 | 000 |
| 24026704660180 | K031383 | 000 |
| 24026704598339 | K031383 | 000 |
| 24026704598315 | K031383 | 000 |
| 24026704598308 | K031383 | 000 |
| 24026704598292 | K031383 | 000 |
| 24026704598209 | K031383 | 000 |
| 24026704598179 | K031383 | 000 |
| 24026704660098 | K031383 | 000 |