Macroduct Advanced Model 3710
FDA 510(k) K180627 · Elitechgroup, Inc.
510(k) numberK180627
Submission
- Device name
- Macroduct Advanced Model 3710
- Applicant
- Elitechgroup, Inc.
Logan, UT, US - Received
- March 9, 2018
- Decision date
- July 27, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTB – Device, Iontophoresis, Specific Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
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| K992874 | Q-Sweat Quantitative Sweat Measurement SystemKTB · Traditional | Wr Medical Electronics Co. | 11/18/1999SE |
| K974855 | Phoresor II, Model PM900KTB · Traditional | Iomed, Inc. | 03/27/1998SN |
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Questions and answers
When was Macroduct Advanced Model 3710 cleared by the FDA?
Macroduct Advanced Model 3710 (K180627) received a 510(k) decision of Substantially Equivalent on July 27, 2018, 140 days after the submission was received.
What is the product code of K180627?
The FDA product code is KTB – Device, Iontophoresis, Specific Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.