The following data is part of a premarket notification filed by Tyco Healthcare Deutschaland Gmbh with the FDA for Respiflo.
| Device ID | K962872 |
| 510k Number | K962872 |
| Device Name: | RESPIFLO |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TYCO HEALTHCARE DEUTSCHALAND GMBH RAFFINERIESTR. 18 Neustadt A D Donau, DE D-93333 |
| Contact | William D Curtin |
| Correspondent | William D Curtin TYCO HEALTHCARE DEUTSCHALAND GMBH RAFFINERIESTR. 18 Neustadt A D Donau, DE D-93333 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-23 |
| Decision Date | 1997-02-25 |
| Summary: | summary |