ELECTRODE IMPEDANCE TESTER-MODEL 500
FDA 510(k) clearance K781475 · decided 1978-09-07
Clearance details
- K-number
- K781475
- Device name
- ELECTRODE IMPEDANCE TESTER-MODEL 500
- Applicant
- Life-Tech Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-08-28
- Decision date
- 1978-09-07
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- GYA
- Device class
- 1
- Regulation number
- 882.1410
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DERMTRODE (K883869) | World Precision Instruments, Inc. | 1988-09-30 |
| RUB E-Z (K854396) | E-Z Instruments Co. | 1986-05-08 |
| AP-CHECK (K830877) | General Devices | 1983-06-08 |
| SC-IT IMPEDANCE TESTER (K820040) | Cadwell Laboratories, Inc. | 1982-01-28 |
Recalls involving this device
No recalls on record reference this clearance.