The following data is part of a premarket notification filed by Foregger with the FDA for I.p.p.b. Manifold/nebulizer (circuit).
| Device ID | K760263 |
| 510k Number | K760263 |
| Device Name: | I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT) |
| Classification | Attachment, Intermittent Mandatory Ventilation (imv) |
| Applicant | FOREGGER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBO |
| CFR Regulation Number | 868.5955 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-21 |
| Decision Date | 1976-08-04 |