The following data is part of a premarket notification filed by Ge Healthcare (ge Medical Systems, Llc) with the FDA for Signa Hero.
Device ID | K213668 |
510k Number | K213668 |
Device Name: | SIGNA Hero |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd. Waukesha, WI 53188 |
Contact | Sandra Westphal |
Correspondent | Sandra Westphal GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd. Waukesha, WI 53188 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-11-22 |
Decision Date | 2022-01-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00195278486813 | K213668 | 000 |