The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Model Vpw2877f8, Mammo 5 Power Supply.
| Device ID | K942778 |
| 510k Number | K942778 |
| Device Name: | MODEL VPW2877F8, MAMMO 5 POWER SUPPLY |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | VARIAN ASSOC., INC. 45 RIVER DR. Georgetown, Ontario, CA L7g2j4 |
| Contact | Anthony B Bailey |
| Correspondent | Anthony B Bailey VARIAN ASSOC., INC. 45 RIVER DR. Georgetown, Ontario, CA L7g2j4 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-13 |
| Decision Date | 1994-07-29 |