The following data is part of a premarket notification filed by Respiraid Ltd. with the FDA for Breathe Easy, Models Ad And Cd.
| Device ID | K981841 |
| 510k Number | K981841 |
| Device Name: | BREATHE EASY, MODELS AD AND CD |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | RESPIRAID LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman RESPIRAID LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-26 |
| Decision Date | 1998-10-13 |
| Summary: | summary |