Last synced on 4 February 2023 at 10:33 pm

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161154
510(k) Type
Traditional
Applicant
SPR THERAPEUTICS, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/23/2016
Days to Decision
89 days
Submission Type
Summary

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161154
510(k) Type
Traditional
Applicant
SPR THERAPEUTICS, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/23/2016
Days to Decision
89 days
Submission Type
Summary