The following data is part of a premarket notification filed by Hpd Medical, Inc. with the FDA for Hpd Sterile Humidifying Chamber.
Device ID | K885314 |
510k Number | K885314 |
Device Name: | HPD STERILE HUMIDIFYING CHAMBER |
Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
Applicant | HPD MEDICAL, INC. 1000 CALLE NEGOCIO San Clemente, CA 92672 -6205 |
Contact | Dunlap |
Correspondent | 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 | 1988-12-29 |
Decision Date | 1989-01-17 |