The following data is part of a premarket notification filed by Hpd Medical, Inc. with the FDA for Hpd Humidifying Chamber.
| Device ID | K864173 |
| 510k Number | K864173 |
| Device Name: | HPD HUMIDIFYING CHAMBER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | HPD MEDICAL, INC. 1000 CALLE NEGOCIO San Clemente, CA 92672 -6205 |
| Contact | C. P Dunlap |
| Correspondent | C. P Dunlap HPD MEDICAL, INC. 1000 CALLE NEGOCIO San Clemente, CA 92672 -6205 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-24 |
| Decision Date | 1987-01-30 |