The following data is part of a premarket notification filed by Charles A. Smith with the FDA for Office Based Anesthesia Machine Mri, Model Oba-1 Mri.
| Device ID | K012446 |
| 510k Number | K012446 |
| Device Name: | OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI |
| Classification | Gas-machine, Anesthesia |
| Applicant | CHARLES A. SMITH 811 STARLITE DR. Louisville, KY 40207 |
| Contact | Charles A Smith |
| Correspondent | Charles A Smith CHARLES A. SMITH 811 STARLITE DR. Louisville, KY 40207 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-01 |
| Decision Date | 2001-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852087007898 | K012446 | 000 |