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INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971273
510(k) Type
Traditional
Applicant
BIO-TEK INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/8/1997
Days to Decision
184 days
Submission Type
Summary

INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971273
510(k) Type
Traditional
Applicant
BIO-TEK INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/8/1997
Days to Decision
184 days
Submission Type
Summary