The following data is part of a premarket notification filed by Radiation Monitoring Devices, Inc. with the FDA for Modification To Gamma Guidance System.
Device ID | K983768 |
510k Number | K983768 |
Device Name: | MODIFICATION TO GAMMA GUIDANCE SYSTEM |
Classification | Probe, Uptake, Nuclear |
Applicant | RADIATION MONITORING DEVICES, INC. 44 HUNT ST. Watertown, MA 02472 -4699 |
Contact | Paul Stoppel |
Correspondent | Paul Stoppel RADIATION MONITORING DEVICES, INC. 44 HUNT ST. Watertown, MA 02472 -4699 |
Product Code | IZD |
CFR Regulation Number | 892.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-26 |
Decision Date | 1999-07-02 |
Summary: | summary |