Last synced on 24 May 2024 at 11:04 pm

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K234080
510(k) Type
Traditional
Applicant
Soterix Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/25/2024
Days to Decision
94 days
Submission Type
Summary

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K234080
510(k) Type
Traditional
Applicant
Soterix Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/25/2024
Days to Decision
94 days
Submission Type
Summary