The following data is part of a premarket notification filed by Ecolab, Inc. with the FDA for #400 Brook Airway & #900 Professional Brook Airway.
| Device ID | K883593 |
| 510k Number | K883593 |
| Device Name: | #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | ECOLAB, INC. ECOLAB CENTER St. Paul, MN 55102 |
| Contact | Ann M Oxford |
| Correspondent | Ann M Oxford ECOLAB, INC. ECOLAB CENTER St. Paul, MN 55102 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-23 |
| Decision Date | 1988-09-30 |