DERMTRODE
FDA 510(k) clearance K883869 · decided 1988-09-30
Clearance details
- K-number
- K883869
- Device name
- DERMTRODE
- Applicant
- World Precision Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-13
- Decision date
- 1988-09-30
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- GYA
- Device class
- 1
- Regulation number
- 882.1410
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- New Haven, CT, 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 |
|---|---|---|
| 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 |
| ELECTRODE IMPEDANCE TESTER-MODEL 500 (K781475) | Life-Tech Instruments, Inc. | 1978-09-07 |
Recalls involving this device
No recalls on record reference this clearance.