The following data is part of a premarket notification filed by Spintech, Inc. with the FDA for Stage.
Device ID | K210843 |
510k Number | K210843 |
Device Name: | STAGE |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | SpinTech, Inc. 30200 Telegraph Road, Suite 140 Bingham Farms, MI 48025 |
Contact | Kay Fuller |
Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2021-03-22 |
Decision Date | 2021-06-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00866463000410 | K210843 | 000 |