The following data is part of a premarket notification filed by Scanditronix Medical Ab with the FDA for Rfa-300, Lda Utility.
| Device ID | K961400 |
| 510k Number | K961400 |
| Device Name: | RFA-300, LDA UTILITY |
| Classification | Accelerator, Linear, Medical |
| Applicant | SCANDITRONIX MEDICAL AB 33 JACKSONVILLE RD. BUILDING 1 Towaco, NJ 07082 |
| Contact | Robert P Morrison |
| Correspondent | Robert P Morrison SCANDITRONIX MEDICAL AB 33 JACKSONVILLE RD. BUILDING 1 Towaco, NJ 07082 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-11 |
| Decision Date | 1997-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EIBAE3050000V0010 | K961400 | 000 |
| EIBAE30420301 | K961400 | 000 |