The following data is part of a premarket notification filed by Siemens Medical Laboratories, Inc. with the FDA for Mevamatic 3.
Device ID | K854609 |
510k Number | K854609 |
Device Name: | MEVAMATIC 3 |
Classification | System, Therapeutic, X-ray |
Applicant | SIEMENS MEDICAL LABORATORIES, INC. 2404 N. MAIN ST. Walnut Creek, CA 94596 |
Contact | Nicol |
Correspondent | Nicol SIEMENS MEDICAL LABORATORIES, INC. 2404 N. MAIN ST. Walnut Creek, CA 94596 |
Product Code | JAD |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-18 |
Decision Date | 1986-02-21 |