The following data is part of a premarket notification filed by Koo Americas, Inc. with the FDA for Koo Americas Valve Peep, Model Km-809.
| Device ID | K050918 |
| 510k Number | K050918 |
| Device Name: | KOO AMERICAS VALVE PEEP, MODEL KM-809 |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | KOO AMERICAS, INC. 1050-C NINE NORTH DRIVE Alpharetta, GA 30004 |
| Contact | William Slevin |
| Correspondent | William Slevin KOO AMERICAS, INC. 1050-C NINE NORTH DRIVE Alpharetta, GA 30004 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-12 |
| Decision Date | 2005-06-06 |
| Summary: | summary |