The following data is part of a premarket notification filed by Automata Medical Instrumentation, Inc. with the FDA for Neo-stat Dialysate Meter.
| Device ID | K920810 |
| 510k Number | K920810 |
| Device Name: | NEO-STAT DIALYSATE METER |
| Classification | Meter, Conductivity, Non-remote |
| Applicant | AUTOMATA MEDICAL INSTRUMENTATION, INC. 7830 EAST REDFIELD RD., SUITE 12 Scottsdale, AZ 85260 |
| Contact | Linda V Masano |
| Correspondent | Linda V Masano AUTOMATA MEDICAL INSTRUMENTATION, INC. 7830 EAST REDFIELD RD., SUITE 12 Scottsdale, AZ 85260 |
| Product Code | FIZ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-21 |
| Decision Date | 1993-01-15 |