The following data is part of a premarket notification filed by Oceanic Medical Products, Inc. with the FDA for Magellan-2200, Model-3 Anesthesia Machine.
| Device ID | K072420 |
| 510k Number | K072420 |
| Device Name: | MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE |
| Classification | Gas-machine, Anesthesia |
| Applicant | OCEANIC MEDICAL PRODUCTS, INC. 555 THIRTEENTH STREET, NW. Washington, DC 20004 |
| Contact | Howard Holstein, Esq |
| Correspondent | Howard Holstein, Esq OCEANIC MEDICAL PRODUCTS, INC. 555 THIRTEENTH STREET, NW. Washington, DC 20004 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-28 |
| Decision Date | 2008-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864604000367 | K072420 | 000 |
| 00864604000343 | K072420 | 000 |