The following data is part of a premarket notification filed by Bird Life Design with the FDA for Hme W/o Filter Hygroflex, Hygroflex-t, Modification.
| Device ID | K934190 |
| 510k Number | K934190 |
| Device Name: | HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | BIRD LIFE DESIGN 4450 ALPHA RD. Dallas, TX 75244 -4505 |
| Contact | Ebecca D Fuller |
| Correspondent | Ebecca D Fuller BIRD LIFE DESIGN 4450 ALPHA RD. Dallas, TX 75244 -4505 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-26 |
| Decision Date | 1993-11-24 |