Last synced on 23 September 2022 at 11:05 pm

EEG MIS MONITOR MODEL # A-2000; BIS ENGINE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011534
510(k) Type
Special
Applicant
ASPECT MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/15/2001
Days to Decision
28 days
Submission Type
Summary

EEG MIS MONITOR MODEL # A-2000; BIS ENGINE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011534
510(k) Type
Special
Applicant
ASPECT MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/15/2001
Days to Decision
28 days
Submission Type
Summary