SC-IT IMPEDANCE TESTER
FDA 510(k) clearance K820040 · decided 1982-01-28
Clearance details
- K-number
- K820040
- Device name
- SC-IT IMPEDANCE TESTER
- Applicant
- Cadwell Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-01-07
- Decision date
- 1982-01-28
- Days to decision
- 21 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
+ Add to Predicate Builder ◉ Watch Cadwell Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| ELECTRODE IMPEDANCE TESTER-MODEL 500 (K781475) | Life-Tech Instruments, Inc. | 1978-09-07 |
Recalls involving this device
No recalls on record reference this clearance.