The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for Rf-ivd Wireless Dosimeter-model 1133.
| Device ID | K011332 |
| 510k Number | K011332 |
| Device Name: | RF-IVD WIRELESS DOSIMETER-MODEL 1133 |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Contact | William E Simon |
| Correspondent | William E Simon SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-02 |
| Decision Date | 2001-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01611370000Z0 | K011332 | 000 |
| B01611360000Z0 | K011332 | 000 |
| 05060608880058 | K011332 | 000 |
| 05060608880041 | K011332 | 000 |