SmartHDM-510 System
FDA 510(k) clearance K201765 · decided 2020-09-02
Clearance details
- K-number
- K201765
- Device name
- SmartHDM-510 System
- Applicant
- Mesa Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-29
- Decision date
- 2020-09-02
- Days to decision
- 65 days
- Clearance type
- Special
- Product code
- FIZ
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Phoenix XL Dialysate Meter (K150657) | Mesa Laboratories, Inc. | 2015-09-21 |
| 90XL INSTRUMENTATION SYSTEM (K050812) | Mesa Laboratories, Inc. | 2005-05-05 |
| HDM97 (K020908) | Ibp Instruments GmbH | 2002-05-22 |
| HDM99 (K020909) | Ibp Instruments GmbH | 2002-05-22 |
| NEO-2 METER (K992431) | Automata Instrumentation, Inc. | 1999-10-13 |
| ODYSSEY INSTRUMENTATION SYSTEM (K981294) | Automata Instrumentation, Inc. | 1998-07-08 |
| 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.