Last synced on 23 February 2024 at 11:04 pm

Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183579
510(k) Type
Traditional
Applicant
Nalu Medical, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/29/2019
Days to Decision
98 days
Submission Type
Summary

Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183579
510(k) Type
Traditional
Applicant
Nalu Medical, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/29/2019
Days to Decision
98 days
Submission Type
Summary