The following data is part of a premarket notification filed by Oceanic Medical Products, Inc. with the FDA for Magellan-2200 Model -2 Anesthesia Machine, Model 2.
| Device ID | K060193 |
| 510k Number | K060193 |
| Device Name: | MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 |
| Classification | Gas-machine, Anesthesia |
| Applicant | OCEANIC MEDICAL PRODUCTS, INC. 555 THIRTEENTH STREET, NW. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein OCEANIC MEDICAL PRODUCTS, INC. 555 THIRTEENTH STREET, NW. Washington, DC 20004 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-25 |
| Decision Date | 2006-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864604000336 | K060193 | 000 |