Last synced on 17 May 2024 at 11:06 pm

INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061163
510(k) Type
Traditional
Applicant
GE MEDICAL SYSTEMS, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/7/2006
Days to Decision
42 days
Submission Type
Summary

INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061163
510(k) Type
Traditional
Applicant
GE MEDICAL SYSTEMS, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/7/2006
Days to Decision
42 days
Submission Type
Summary