510(k) K183585
- Device
- Elitone Device
- Applicant
- Elidah, Inc.
- 510(k) number
- K183585
- Product code
- QAJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-02-11
- Date received
- 2018-12-21
- Regulation
- 876.5330
- Classification name
- Cutaneous Electrode Stimulator For Urinary Incontinence
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gloria Kolb
- Address
- 810 Main St. Suite C Monroe CT US 06468 06468
FDA Registration Numbers#
- 3003990090
- 3014915464
Source Documents#
Other 510(k) Records For Product Code QAJ #
Legacy Summary#
summary