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 |