BIPAP FOCUS
Ventilator, Continuous, Non-life-supporting
RESPIRONICS (IRELAND) LIMITED
The following data is part of a premarket notification filed by Respironics (ireland) Limited with the FDA for Bipap Focus.
Pre-market Notification Details
| Device ID | K053168 |
| 510k Number | K053168 |
| Device Name: | BIPAP FOCUS |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | RESPIRONICS (IRELAND) LIMITED PARKMORE BUSINESS PARK, PARKMORE WEST Galway, IE |
| Contact | John O'dea |
| Correspondent | John O'dea RESPIRONICS (IRELAND) LIMITED PARKMORE BUSINESS PARK, PARKMORE WEST Galway, IE |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2006-01-04 |
| Summary: | summary |
Trademark Results [BIPAP FOCUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIPAP FOCUS 78621138 3357232 Dead/Cancelled |
RIC Investments, LLC 2005-05-02 |
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