The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Smooth-flo Circuit.
| Device ID | K010402 |
| 510k Number | K010402 |
| Device Name: | SMOOTH-FLO CIRCUIT |
| 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 | 2001-02-12 |
| Decision Date | 2001-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704660333 | K010402 | 000 |
| 24026704660326 | K010402 | 000 |
| 24026704660302 | K010402 | 000 |
| 24026704598285 | K010402 | 000 |
| 24026704598278 | K010402 | 000 |
| 24026704598261 | K010402 | 000 |
| 24026704598254 | K010402 | 000 |