Last synced on 13 June 2025 at 11:06 pm

PIKOS E 01-B

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K941937
510(k) Type
Traditional
Applicant
BIOTRONIK, INC.
Country
United States
FDA Decision
Substantially Equivalent - PostMarket Surveillance Required
Decision Date
8/30/1994
Days to Decision
131 days
Submission Type
Summary

PIKOS E 01-B

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K941937
510(k) Type
Traditional
Applicant
BIOTRONIK, INC.
Country
United States
FDA Decision
Substantially Equivalent - PostMarket Surveillance Required
Decision Date
8/30/1994
Days to Decision
131 days
Submission Type
Summary