The following data is part of a premarket notification filed by Oceanic Medical Products, Inc. with the FDA for Magellan-2200, Model 1.
| Device ID | K010613 |
| 510k Number | K010613 |
| Device Name: | MAGELLAN-2200, MODEL 1 |
| Classification | Gas-machine, Anesthesia |
| 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 | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-01 |
| Decision Date | 2001-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864604000329 | K010613 | 000 |