The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for American Pharmaseal Humidair Condenser.
| Device ID | K854012 |
| 510k Number | K854012 |
| Device Name: | AMERICAN PHARMASEAL HUMIDAIR CONDENSER |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Contact | Robert T Merrick |
| Correspondent | Robert T Merrick AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-30 |
| Decision Date | 1985-12-03 |