The following data is part of a premarket notification filed by Radiation Monitoring Devices, Inc. with the FDA for Gamma Guidance System.
| Device ID | K961321 |
| 510k Number | K961321 |
| Device Name: | 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 | 1996-04-05 |
| Decision Date | 1997-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521184463 | K961321 | 000 |
| 20884521170282 | K961321 | 000 |