NEO-2 METER
FDA 510(k) clearance K992431 · decided 1999-10-13
Clearance details
- K-number
- K992431
- Device name
- NEO-2 METER
- Applicant
- Automata Instrumentation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-21
- Decision date
- 1999-10-13
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FIZ
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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| PHOENIX DIALYSATE METER (K955298) | Automata Medical Instrumentation, Inc. | 1996-02-29 |
| NEO-STAT DIALYSATE METER (K920810) | Automata Medical Instrumentation, Inc. | 1993-01-15 |
| MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER (K881098) | Automata, Inc. | 1988-04-21 |
| NEO-I TEMPERATURE & CONDUCTIVITY METER (K871708) | Automata, Inc. | 1987-06-17 |
| COLORADO MEDICAL MODEL CTM-3000 (K853735) | Colorado Medical, Inc. | 1985-10-04 |
| MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT (K780932) | Western Laboratories Corp. | 1978-08-31 |
Recalls involving this device
No recalls on record reference this clearance.