The following data is part of a premarket notification filed by Gibeck Respiration with the FDA for Humid-vent Filter.
| Device ID | K881657 |
| 510k Number | K881657 |
| Device Name: | HUMID-VENT FILTER |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | GIBECK RESPIRATION 165 E. COMMERCE DR. Shaumburg, IL 60173 |
| Contact | Darryl Lustig |
| Correspondent | Darryl Lustig GIBECK RESPIRATION 165 E. COMMERCE DR. Shaumburg, IL 60173 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-15 |
| Decision Date | 1988-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704388749 | K881657 | 000 |
| 24026704388312 | K881657 | 000 |