The following data is part of a premarket notification filed by Webb Research, Inc. with the FDA for Power Scan 1000.
Device ID | K910802 |
510k Number | K910802 |
Device Name: | POWER SCAN 1000 |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | WEBB RESEARCH, INC. 74 DICKINSON ST. Philadelphia, PA 19147 |
Contact | Steven Krupnick |
Correspondent | Steven Krupnick WEBB RESEARCH, INC. 74 DICKINSON ST. Philadelphia, PA 19147 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-26 |
Decision Date | 1991-05-09 |