The following data is part of a premarket notification filed by Elidah, Inc. with the FDA for Elitone Device.
Device ID | K183585 |
510k Number | K183585 |
Device Name: | Elitone Device |
Classification | Cutaneous Electrode Stimulator For Urinary Incontinence |
Applicant | Elidah, Inc. 810 Main St., Ste C Monroe, CT 06468 |
Contact | Gloria Kolb |
Correspondent | Gloria Kolb Elidah, Inc. 810 Main St., Ste C Monroe, CT 06468 |
Product Code | QAJ |
CFR Regulation Number | 876.5330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-21 |
Decision Date | 2019-02-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851096008018 | K183585 | 000 |
00851096008001 | K183585 | 000 |
00851096008025 | K183585 | 000 |