The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Conchatherm Iv Heated Molecular Humidifier.
| Device ID | K923946 |
| 510k Number | K923946 |
| Device Name: | CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Contact | William H Murphy |
| Correspondent | William H Murphy 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-05 |
| Decision Date | 1994-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784570136 | K923946 | 000 |
| 24026704659610 | K923946 | 000 |
| 24026704659603 | K923946 | 000 |
| 24026704659504 | K923946 | 000 |
| 14026704396372 | K923946 | 000 |