The following data is part of a premarket notification filed by Helix Medical, Inc. with the FDA for Blom-singer Humid/fil Syst Inhealth In-line Humid..
| Device ID | K915786 |
| 510k Number | K915786 |
| Device Name: | BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | HELIX MEDICAL, INC. 210 SANTA BARBERA ST. Santa Barbera, CA 93101 |
| Contact | Christine Emanuel |
| Correspondent | Christine Emanuel HELIX MEDICAL, INC. 210 SANTA BARBERA ST. Santa Barbera, CA 93101 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-06-30 |