The following data is part of a premarket notification filed by Hpd Medical, Inc. with the FDA for Hpd Heater Bases.
| Device ID | K914994 |
| 510k Number | K914994 |
| Device Name: | HPD HEATER BASES |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| 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 | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-07 |
| Decision Date | 1993-02-12 |