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SMARTEP-ASSR, MODEL M811007

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K031051
510(k) Type
Traditional
Applicant
INTELLIGENT HEARING SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/20/2004
Days to Decision
324 days
Submission Type
Summary

SMARTEP-ASSR, MODEL M811007

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K031051
510(k) Type
Traditional
Applicant
INTELLIGENT HEARING SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/20/2004
Days to Decision
324 days
Submission Type
Summary