The following data is part of a premarket notification filed by Prym Medical Ltd. with the FDA for Sansibar Cpap System.
| Device ID | K000888 |
| 510k Number | K000888 |
| Device Name: | SANSIBAR CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | PRYM MEDICAL LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman PRYM MEDICAL LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-20 |
| Decision Date | 2000-08-15 |