ELECTRODE USING PROMEON RG-60 SERIES GEL
FDA 510(k) clearance K915333 · decided 1992-01-14
Clearance details
- K-number
- K915333
- Device name
- ELECTRODE USING PROMEON RG-60 SERIES GEL
- Applicant
- Labeltape Meditect, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-26
- Decision date
- 1992-01-14
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Grand Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Labeltape Meditect
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous elec recall (Z-0500-2013) | Covidien LLC dba Uni-Patch | 2012-12-10 |