The following data is part of a premarket notification filed by Oceanic Medical Products, Inc. with the FDA for Magellan Ventilator.
| Device ID | K002951 |
| 510k Number | K002951 |
| Device Name: | MAGELLAN VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | OCEANIC MEDICAL PRODUCTS, INC. 8005 SHANNON INDUSTRIAL PARK LN. Atchison, KS 66002 |
| Contact | William M Gates |
| Correspondent | William M Gates OCEANIC MEDICAL PRODUCTS, INC. 8005 SHANNON INDUSTRIAL PARK LN. Atchison, KS 66002 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-21 |
| Decision Date | 2000-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864604000312 | K002951 | 000 |
| 00864604000305 | K002951 | 000 |