MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT
FDA 510(k) clearance K780932 · decided 1978-08-31
Clearance details
- K-number
- K780932
- Device name
- MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT
- Applicant
- Western Laboratories Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-06
- Decision date
- 1978-08-31
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- FIZ
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
Recalls involving this device
No recalls on record reference this clearance.